- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07391514
Deep Learning-Based Intraoperative Dual-tracer Video Analysis of Sentinel Lymph Node Mapping for Metastasis Prediction in cN0 Papillary Thyroid Carcinoma
Deep Learning-Based Intraoperative Dual-tracer Video Analysis of Sentinel Lymph Node Mapping for Metastasis Prediction in cN0 Papillary Thyroid Carcinoma: A Prospective Cohort Study
The goal of this observational study is to learn if a computer program (deep learning) can accurately predict lymph node spread in adults with papillary thyroid cancer who have no signs of lymph node involvement before surgery (called cN0). The main questions it aims to answer are:
- Can video analysis of lymph node mapping during surgery predict if cancer has spread to lymph nodes beyond the first-draining (sentinel) lymph node?
- Can this prediction help surgeons decide how much tissue to remove during surgery?
During surgery, participants will receive an injection of two special dyes (carbon nanoparticles and indocyanine green) near the thyroid tumor. These dyes travel through the lymphatic system and help surgeons see the lymph nodes. A special camera records a video of how the dyes move and light up the lymph nodes.
Researchers will use computer programs to analyze these videos along with other medical information (such as ultrasound results and tumor characteristics) to predict whether cancer has spread to additional lymph nodes. The predictions will be compared against the actual results from tissue samples examined after surgery.
Participants will receive standard thyroid cancer surgery. The study does not change the surgical treatment. The video recording adds no extra risk to participants.
Study Overview
Status
Conditions
Detailed Description
BACKGROUND AND RATIONALE:
Papillary thyroid carcinoma (PTC) is one of the fastest-growing cancers worldwide. A major challenge in treating PTC is that 30% to 80% of patients who appear to have no lymph node involvement before surgery (clinically node-negative, or cN0) actually have hidden (occult) cancer spread to their lymph nodes. Current imaging methods like ultrasound often miss these small areas of cancer spread.
This creates a difficult decision for surgeons: removing too many lymph nodes increases the risk of complications such as damage to the parathyroid glands (which control calcium levels) and the nerves that control the voice. However, removing too few lymph nodes may leave cancer behind, which can lead to recurrence.
Sentinel lymph node (SLN) mapping is a technique that identifies the first lymph nodes that drain from a tumor. The idea is that if cancer spreads through the lymphatic system, it will reach these sentinel nodes first. However, current single-tracer methods for SLN mapping in thyroid cancer have limitations and variable results.
This study uses a dual-tracer approach that combines two different dyes:
- Carbon nanoparticles (CNs): These provide long-lasting black staining that helps surgeons see lymph nodes clearly
- Indocyanine green (ICG): This dye glows under near-infrared light, allowing real-time visualization of lymphatic flow
By combining these two tracers, surgeons can see both the structure of lymph nodes and how lymphatic fluid flows through them over time.
STUDY DESIGN:
This is a prospective, single-center, observational cohort study. The study does not change the surgical treatment that participants receive. All participants undergo standard thyroid cancer surgery with lymph node removal as determined by their surgical team.
STUDY PROCEDURES:
Pre-operative Assessment:
All participants undergo standard pre-operative evaluation including:
- Physical examination
- Thyroid ultrasound with detailed lymph node assessment
- Fine-needle aspiration biopsy to confirm PTC diagnosis
- Genetic testing for common mutations (such as BRAF)
- Standard blood tests
Surgical Procedure:
During surgery, participants receive the dual-tracer injection under ultrasound guidance. The injection is given at multiple points around the thyroid tumor. The specific preparation is:
- 0.1 ml of ICG solution (concentration: 2.5 mg/ml)
- 0.1 ml of carbon nanoparticle suspension (concentration: 50 mg/ml) These are mixed together and injected using precise, multi-point technique.
Video Recording:
A near-infrared fluorescence imaging system records the entire process of lymph node visualization. The recording captures:
- How the dyes spread through the lymphatic channels
- When each lymph node first becomes visible
- How the fluorescence signal changes over time
- The pattern of lymphatic drainage
Videos are recorded at high resolution (1920 × 1080 pixels) at approximately 30 frames per second. A standardized 3-minute segment is extracted from each video for analysis, providing 150 frames per patient.
Surgical Decisions:
The sentinel lymph node (the first node that lights up) is removed and sent for immediate frozen section analysis. Based on standard criteria, surgeons decide whether to perform:
- Ipsilateral central lymph node dissection (removing lymph nodes on the same side as the tumor)
- Lateral lymph node dissection (if certain criteria are met)
- Contralateral central dissection (removing lymph nodes on the opposite side)
These decisions follow the standard surgical protocol at our institution and are not influenced by the deep learning predictions.
- Pathological Examination:
All removed lymph nodes are examined by pathologists to determine:
- Whether the sentinel lymph node contains cancer (SLNM status)
- Whether second-echelon lymph nodes contain cancer (SeLNM)
- Whether non-sentinel lymph nodes contain cancer (NsLNM)
- The number and location of all positive lymph nodes
DATA COLLECTION AND ANALYSIS:
Clinical Data (32 variables):
- Demographics: age, sex, body mass index
- Ultrasound features: tumor size, location, margins, calcification patterns, aspect ratio, TI-RADS classification
- Pathological features: multifocality, extrathyroidal extension, capsular invasion
- Genetic data: BRAF mutation status and other relevant mutations
Video Analysis:
Two experienced surgeons (each with more than 10 years of experience) manually identify and outline the regions of interest (the sentinel lymph nodes) in each video frame. This creates 19,650 mask images across all participants.
Feature Extraction:
The deep learning system extracts multiple types of features:
Spatial Features (2,048 dimensions):
- Image features from a pre-trained neural network (EfficientNet-B5)
- Grayscale characteristics
- Shape and morphological features
- Hu moment descriptors (mathematical descriptions of shape)
Temporal Features (20 dimensions):
- Frame-to-frame differences showing how the image changes
- Optical flow measurements showing movement patterns
- Fluorescence intensity changes over time
- Flow velocity measurements at specific time points
DEEP LEARNING MODELS:
Nine different deep learning architectures are developed and compared:
- Convolutional Neural Network (CNN): Extracts local spatial features from images
- Long Short-Term Memory (LSTM): Captures patterns in time-series data
- CNN + LSTM: Combines spatial and temporal feature extraction
- CNN + LSTM + Attention: Adds attention mechanism to focus on important time points
- Transformer: Uses self-attention to capture global patterns in sequential data
- Crossformer: A specialized architecture for time-series analysis
- 3D-CNN: Processes video data as three-dimensional volumes
- LSTM + Transformer: Hybrid model combining LSTM and Transformer strengths
- LSTM + Crossformer: Hybrid model combining LSTM and Crossformer
All models use:
- Binary cross-entropy loss function
- Adam optimizer for training
- Data augmentation (rotation, scaling, noise injection) to prevent overfitting
- Weighted loss functions to handle class imbalance
- Dropout regularization
MODEL EVALUATION:
Models are evaluated using 10-fold stratified cross-validation, ensuring balanced distribution of outcomes in training and testing sets. Performance metrics include:
- Area Under the ROC Curve (AUC): Measures overall discrimination ability
- Accuracy: Percentage of correct predictions
- Sensitivity: Ability to correctly identify patients with metastasis
- Specificity: Ability to correctly identify patients without metastasis
- Positive Predictive Value: Probability that a positive prediction is correct
- Negative Predictive Value: Probability that a negative prediction is correct
- F1 Score: Balance between precision and recall
- Brier Score: Calibration of predicted probabilities
Additional analyses include:
- Decision curve analysis to assess clinical utility
- Calibration curves to check prediction reliability
- Learning curves to assess overfitting
- DeLong test for statistical comparison between models
- Probability-based model ranking approach (PMRA)
MODEL INTERPRETABILITY:
To understand how the model makes predictions, we use SHapley Additive exPlanations (SHAP) analysis. This technique:
- Identifies which features contribute most to predictions
- Shows how each feature affects individual predictions
- Reveals whether the model relies on clinically meaningful factors
- Provides transparency into the "black box" of deep learning
OUTCOMES:
Primary Outcomes:
- Second-echelon lymph node metastasis (SeLNM): Cancer spread to lymph nodes beyond the sentinel node in the drainage pathway
- Non-sentinel lymph node metastasis (NsLNM): Cancer spread to any lymph node other than the sentinel node
Both outcomes are determined by final pathological examination of surgically removed tissue (the gold standard).
Secondary Outcomes:
- Model performance metrics (AUC, sensitivity, specificity, etc.)
- Feature importance rankings from SHAP analysis
- Comparison of model architectures
STATISTICAL CONSIDERATIONS:
Sample Size:
Based on power calculations assuming:
- Alpha = 0.05 (significance level)
- Power = 0.80
- Expected sensitivity difference of 20% between methods
- Expected prevalence of lymph node metastasis of 50%
A minimum of 335 participants was calculated. Due to strict inclusion criteria and video quality requirements, 131 participants with complete, high-quality data were included in the final analysis.
Statistical Methods:
- Descriptive statistics for baseline characteristics
- Chi-square or Fisher exact test for categorical variables
- Mann-Whitney U test for continuous variables
- DeLong test for comparing AUC values between models
- 95% confidence intervals for all performance metrics
FOLLOW-UP:
While the primary analysis focuses on intraoperative prediction, participants are followed according to standard clinical care protocols. Long-term outcomes including recurrence-free survival may be analyzed in future studies.
ETHICAL CONSIDERATIONS:
This study was approved by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University (Approval No. 2023-322). All participants provided written informed consent before enrollment.
The study poses minimal additional risk to participants because:
- The dual-tracer injection uses agents already approved for clinical use
- The video recording is non-invasive and does not affect surgical decisions
- All surgical decisions are made according to standard protocols
- The deep learning analysis is performed retrospectively and does not influence treatment
POTENTIAL IMPACT:
If successful, this approach could:
- Help surgeons make more informed decisions about the extent of lymph node removal
- Reduce unnecessary extensive surgery in low-risk patients
- Ensure adequate surgery in high-risk patients who might otherwise be undertreated
- Provide real-time, objective decision support during surgery
- Standardize the interpretation of lymphatic mapping across different surgeons and centers
- Serve as a training tool for less experienced surgeons
LIMITATIONS:
- Single-center study, which may limit generalizability
- Relatively small sample size due to strict quality requirements
- Manual annotation of regions of interest may introduce variability
- Deep learning models require validation in external cohorts
- Real-time implementation during surgery requires further development
FUTURE DIRECTIONS:
- External validation in multiple centers
- Development of real-time prediction software for intraoperative use
- Integration with other imaging modalities
- Prospective interventional trials to assess clinical benefit of AI-guided surgery
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Chongqing, China, 400016
- The First Affiliated Hospital of Chongqing Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older at the time of enrollment
- Histologically confirmed papillary thyroid carcinoma (PTC) by preoperative fine-needle aspiration biopsy
- Clinically node-negative (cN0) status confirmed by preoperative imaging (ultrasound and/or cross-sectional imaging showing no evidence of lymph node metastasis)
- Scheduled to undergo thyroid surgery with simultaneous central lymph node dissection
- Willing and able to provide written informed consent
Complete preoperative clinical data available, including:
- Demographic information (age, sex, body mass index)
- Thyroid ultrasound report with detailed tumor characteristics
- Fine-needle aspiration biopsy pathology report
- Genetic testing results (when available)
- Able to undergo intraoperative dual-tracer sentinel lymph node mapping with near-infrared fluorescence video recording
Exclusion Criteria:
- History of previous neck surgery (including thyroid surgery, parathyroid surgery, or other cervical operations)
- History of external beam radiotherapy to the head and neck region
- Diagnosis of thyroid malignancy other than papillary thyroid carcinoma (e.g., follicular thyroid carcinoma, medullary thyroid carcinoma, anaplastic thyroid carcinoma, or thyroid lymphoma)
- Known allergy or hypersensitivity to indocyanine green (ICG), iodine, or carbon nanoparticles
- Severe hepatic insufficiency (ICG is metabolized by the liver)
- Pregnancy or breastfeeding
- Incomplete medical records or missing essential preoperative data
- Refusal to undergo dual-tracer imaging procedure
- Inability to obtain satisfactory intraoperative near-infrared fluorescence video recording due to technical issues or poor image quality
- Participation in another interventional clinical trial that may interfere with the current study
- Any condition that, in the investigator's opinion, would compromise the participant's safety or the quality of the study data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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ICG Group
Adults with clinically node-negative papillary thyroid carcinoma (cN0-PTC) who undergo intraoperative sentinel lymph node mapping using indocyanine green (ICG) alone. Intervention: 0.2 ml of ICG solution (concentration: 2.5 mg/ml) injected at multiple points around the thyroid tumor under ultrasound guidance. Near-infrared fluorescence imaging is used to visualize lymphatic drainage and identify sentinel lymph nodes. Participants undergo standard thyroid surgery including thyroid lobectomy and central lymph node dissection, with additional dissection based on intraoperative findings. |
Intraoperative sentinel lymph node mapping using carbon nanoparticle suspension with visual identification. Preparation: Carbon nanoparticle suspension is used at the commercial concentration of 50 mg/ml. Administration: 0.2 ml of carbon nanoparticle suspension is injected at multiple points around the thyroid tumor under real-time ultrasound guidance using a precision multi-point stereotactic injection technique. Visualization: Carbon nanoparticles (diameter 150 nm) selectively enter lymphatic channels and accumulate in lymph nodes, producing visible black staining. Surgeons identify sentinel lymph nodes by direct visual inspection of black-stained nodes. The sentinel lymph node is defined as the first lymph node that shows black staining after tracer injection.
Other Names:
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CNs Group
Adults with clinically node-negative papillary thyroid carcinoma (cN0-PTC) who undergo intraoperative sentinel lymph node mapping using carbon nanoparticles (CNs) alone. Intervention: 0.2 ml of carbon nanoparticle suspension (concentration: 50 mg/ml) injected at multiple points around the thyroid tumor under ultrasound guidance. Black staining is used to visualize lymph nodes during surgery. Participants undergo standard thyroid surgery including thyroid lobectomy and central lymph node dissection, with additional dissection based on intraoperative findings. |
Intraoperative sentinel lymph node mapping using indocyanine green (ICG) with near-infrared fluorescence imaging. Preparation: ICG powder (25 mg) is dissolved in 10 ml sterile water to achieve a concentration of 2.5 mg/ml. Administration: 0.2 ml of ICG solution is injected at multiple points around the thyroid tumor under real-time ultrasound guidance using a precision multi-point stereotactic injection technique. Visualization: A near-infrared fluorescence imaging system (excitation wavelength 750-800 nm, emission wavelength 820 nm) is used to visualize lymphatic channels and identify sentinel lymph nodes in real time during surgery. The sentinel lymph node is defined as the first lymph node that shows fluorescence signal after tracer injection.
Other Names:
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ICG+CNs Group (Dual-Tracer)
Adults with clinically node-negative papillary thyroid carcinoma (cN0-PTC) who undergo intraoperative sentinel lymph node mapping using combined indocyanine green and carbon nanoparticles (dual-tracer technique). Intervention: A mixture of 0.1 ml ICG solution (concentration: 2.5 mg/ml) and 0.1 ml carbon nanoparticle suspension (concentration: 50 mg/ml) injected at multiple points around the thyroid tumor under ultrasound guidance. Near-infrared fluorescence imaging combined with visual black staining is used to visualize lymphatic drainage and identify sentinel lymph nodes. This group also undergoes deep learning video analysis of the fluorescence imaging process to predict lymph node metastasis. Participants undergo standard thyroid surgery including thyroid lobectomy and central lymph node dissection, with additional dissection based on intraoperative findings. |
Intraoperative sentinel lymph node mapping using combined indocyanine green and carbon nanoparticles with near-infrared fluorescence imaging and visual identification. Preparation: 0.1 ml of ICG solution (2.5 mg/ml) is mixed with 0.1 ml of carbon nanoparticle suspension (50 mg/ml) to form a 0.2 ml dual-tracer composite agent. Administration: The mixed tracer is injected at multiple points around the thyroid tumor under real-time ultrasound guidance using a precision multi-point stereotactic injection technique. Visualization: Near-infrared fluorescence imaging captures real-time lymphatic flow dynamics (ICG component), while black staining provides durable visual lymph node identification (CNs component). Video recording documents the entire sentinel lymph node visualization process for at least 5 minutes at 1920x1080 resolution. Deep learning analysis: In this group, video recordings are analyzed using nine deep learning models to extract spatiotemporal features and predict second
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sentinel Lymph Node Metastasis (SLNM) Status
Time Frame: immediately after the surgery
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The presence or absence of cancer metastasis in the sentinel lymph node, determined by postoperative histopathological examination (paraffin section) as the gold standard.
SLNM is classified as positive (macrometastasis or micrometastasis present) or negative (no metastasis).
The SLNM rate is calculated as: number of participants with positive sentinel lymph nodes divided by total number of participants with successfully identified sentinel lymph nodes.
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immediately after the surgery
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Sentinel Lymph Node Detection Rate
Time Frame: immediately after the surgery
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The proportion of participants in whom sentinel lymph nodes are successfully identified using each tracer method (ICG alone, CNs alone, or ICG+CNs dual-tracer).
A sentinel lymph node is defined as the first lymph node visualized after tracer injection.
Detection rate is calculated as: number of participants with successfully identified sentinel lymph nodes divided by total number of participants in each group, expressed as a percentage.
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immediately after the surgery
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Second-Echelon Lymph Node Metastasis (SeLNM)
Time Frame: perioperatively
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The presence or absence of cancer metastasis in second-echelon lymph nodes (lymph nodes beyond the sentinel node in the lymphatic drainage pathway), determined by postoperative histopathological examination.
SeLNM is the primary prediction target for the deep learning models in the ICG+CNs group.
SeLNM status is classified as positive or negative based on paraffin section pathology results.
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perioperatively
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Non-Sentinel Lymph Node Metastasis (NsLNM)
Time Frame: perioperatively
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The presence or absence of cancer metastasis in any lymph node other than the sentinel lymph node, determined by postoperative histopathological examination.
NsLNM includes metastasis in central compartment nodes (prelaryngeal, pretracheal, paratracheal, and nodes posterior to recurrent laryngeal nerve) and lateral compartment nodes when dissected.
NsLNM is the second primary prediction target for the deep learning models in the ICG+CNs group.
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perioperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sensitivity of Sentinel Lymph Node Mapping
Time Frame: through study completion, an average of 1 year
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The ability of each tracer method to correctly identify participants who have lymph node metastasis.
Sensitivity is calculated as: true positives divided by (true positives + false negatives), expressed as a percentage.
A true positive is defined as a positive sentinel lymph node in a participant with confirmed central lymph node metastasis on final pathology.
Compared among ICG, CNs, and ICG+CNs groups.
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through study completion, an average of 1 year
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Specificity of Sentinel Lymph Node Mapping
Time Frame: through study completion, an average of 1 year
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The ability of each tracer method to correctly identify participants who do not have lymph node metastasis.
Specificity is calculated as: true negatives divided by (true negatives + false positives), expressed as a percentage.
A true negative is defined as a negative sentinel lymph node in a participant with no central lymph node metastasis on final pathology.
Compared among ICG, CNs, and ICG+CNs groups.
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through study completion, an average of 1 year
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Positive Predictive Value (PPV) of Sentinel Lymph Node Mapping
Time Frame: through study completion, an average of 1 year
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The probability that participants with a positive sentinel lymph node truly have central lymph node metastasis.
PPV is calculated as: true positives divided by (true positives + false positives), expressed as a percentage.
Compared among ICG, CNs, and ICG+CNs groups.
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through study completion, an average of 1 year
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Negative Predictive Value (NPV) of Sentinel Lymph Node Mapping
Time Frame: through study completion, an average of 1 year
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The probability that participants with a negative sentinel lymph node truly do not have central lymph node metastasis.
NPV is calculated as: true negatives divided by (true negatives + false negatives), expressed as a percentage.
A high NPV indicates that a negative sentinel lymph node reliably rules out metastatic disease.
Compared among ICG, CNs, and ICG+CNs groups.
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through study completion, an average of 1 year
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Deep Learning Model Performance - Area Under ROC Curve (AUC)
Time Frame: through study completion, an average of 1 year
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The area under the receiver operating characteristic curve for each deep learning model (CNN, LSTM, CNN+LSTM, CNN+LSTM+Attention, Transformer, Crossformer, 3D-CNN, LSTM+Transformer, LSTM+Crossformer) in predicting SeLNM and NsLNM in the ICG+CNs group.
AUC ranges from 0 to 1, with higher values indicating better discrimination.
Evaluated using 10-fold stratified cross-validation.
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through study completion, an average of 1 year
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Deep Learning Model Performance - Accuracy, Sensitivity, and Specificity
Time Frame: through study completion, an average of 1 year
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Performance metrics of the optimal deep learning model for predicting SeLNM and NsLNM in the ICG+CNs group.
Accuracy is the proportion of correct predictions.
Sensitivity is the proportion of actual positive cases correctly identified.
Specificity is the proportion of actual negative cases correctly identified.
All metrics expressed as percentages with 95% confidence intervals.
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through study completion, an average of 1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Sentinel Lymph Nodes Identified
Time Frame: immediately after surgery
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The mean number of sentinel lymph nodes identified per participant using each tracer method.
Compared among ICG, CNs, and ICG+CNs groups using appropriate statistical tests.
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immediately after surgery
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Total Number of Lymph Nodes Retrieved
Time Frame: perioperatively
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The total number of lymph nodes retrieved during central and lateral lymph node dissection per participant.
Reported as mean with standard deviation for each group.
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perioperatively
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Feature Importance from SHAP Analysis
Time Frame: through study completion, an average of 1 year
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Identification and ranking of the most important predictive features contributing to the deep learning model predictions, determined by SHapley Additive exPlanations (SHAP) analysis.
Features include temporal fluorescence-flow characteristics, spatial structural features, and clinical variables.
Reported as mean absolute SHAP values for top contributing features.
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through study completion, an average of 1 year
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Surgical Complications
Time Frame: up to 24 weeks
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Incidence of surgery-related complications including: transient or permanent hypoparathyroidism (based on postoperative calcium and parathyroid hormone levels), transient or permanent recurrent laryngeal nerve injury (based on postoperative laryngoscopy), postoperative bleeding requiring intervention, and wound infection.
Reported as number and percentage of participants in each group.
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up to 24 weeks
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Tracer-Related Adverse Events
Time Frame: perioperatively
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Incidence of adverse events related to tracer injection, including allergic reactions, injection site reactions, and any other tracer-associated complications.
ICG-related adverse events are expected to be less than 0.05% based on published literature.
Reported as number and percentage of participants in each group.
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perioperatively
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Collaborators and Investigators
Investigators
- Study Director: Xinliang Su, MD,PhD, First Affiliated Hospital of Chongqing Medical University
- Study Chair: Han Gao, MD,PhD, Women and Children's Hospital of Chongqing Medical University
- Principal Investigator: Xinliang Su, MD,PhD, First Affiliated Hospital of Chongqing Medical University
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1stChongqingMU-sxl
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
A decision regarding individual participant data sharing has not yet been finalized. The study team is currently evaluating:
- Technical feasibility of de-identifying video-based imaging data
- Institutional and ethical requirements for data sharing
- Development of appropriate data use agreements
The IPD sharing plan will be updated prior to publication of the primary study results. Interested researchers may contact the Principal Investigator (suxinliang@21cn.com) to discuss potential future data access.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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