Exploratory Study on NIRFI Technology Combined with ICG Guided Cervical Cancer Lymph Node Metastasis

Exploratory Study on Near-Infrared Fluorescence Imaging Technology Combined with Indocyanine Green Guided Cervical Cancer Lymph Node Metastasis

The goal of this exploratory study is to exploring the lymph node metastasis, tumor margin, blood vessels, ureters, and nerve imaging in cervical cancer surgery using near-infrared fluorescence imaging technology combined with indocyanine green, and establishing an artificial intelligence model for predicting lymph node metastasis of cervical cancer to guide the advancement of refined surgical procedures.And the focus of this study is to investigate the situation of pelvic lymph node metastasis.The sole medication used in this experiment is the fluorescent contrast agent that has been clinically used for over 40 years - Indocyanine Green (ICG).Subsequent pathology results after the surgery will be used as the gold standard to determine the detection rate of lymph node metastasis and the accuracy of the complete resection rate of the surgical margin in cervical cancer.The researchers will also follow up on the quality of life of patients after the surgery.

The main question it aims to answer is:

can artificial intelligence multimodal fusion prediction models improve the accuracy of preoperative diagnosis of pelvic lymph node metastasis in cervical cancer? The researchers compared the AI multimodal fusion prediction model with traditional imaging physician assessments to see if the prediction model could yield more accurate lymph node metastasis determinations. Participants will undergo pelvic MRI after pathologically confirming a diagnosis of cervical cancer, and the results will be used to determine pelvic lymph node metastasis status by the predictive model and the imaging physician, respectively. Subsequent pathology results after surgical lymph node clearance will be used as the gold standard to determine the accuracy of the two preoperative lymph node diagnostic modalities.

Study Overview

• Status: Recruiting
• Conditions: Uterine Cervical Neoplasms
• Intervention / Treatment: Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200090
      • Recruiting
      • The Obstetrics and Gynecology Hospital of Fudan University
      • Contact: Wu Xin; Phone Number: 8613764046908 86-02133189900; Email: wuxin_fc@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with primary cervical cancer stages I to III, with no restrictions on pathological type.
2. Age ≥18 years old and ≤75 years old.
3. Patients who have undergone radical hysterectomy/modified radical hysterectomy (referring to the Q-M surgery classification, with surgical methods of type B and type C) + pelvic lymph node dissection.
4. Patients with complete preoperative clinical and postoperative pathological data.
5. Normal liver and kidney function and within the normal range of blood routine tests (specific details are as follows): Hemoglobin >60 g/L; Platelets >70 * 10^9/L; White blood cells >3 * 10^9/L; Creatinine <50 mg/dL; Abnormal liver enzyme indicators ≤3 items; The highest value of liver enzymes does not exceed three times the corresponding normal value.
6. No history of other malignant tumors within 5 years.
7. Not pregnant.
8. Performance status: Karnofsky score ≥60 points or ECOG score 0 to 1 points.
9. Volunteers who willingly join this study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
10. No mental illness or other serious infectious diseases or immune system diseases (such as lupus erythematosus, myasthenia gravis, HIV infection, etc.)

Exclusion Criteria:

1. Patients with allergies to ICG or iodine. Individuals with contraindications to various surgeries who cannot undergo surgery.
2. Patients with recurrent cervical cancer.
3. Patients who have participated in other clinical trials within the past 3 months.
4. Other conditions deemed unsuitable for inclusion in this study by the 5.investigator, or patients with other underlying diseases that may confound the study results.

6.Patients who are assessed preoperatively as having systemic and organ conditions that are unlikely to tolerate surgery.

7.Patients or guardians who are unwilling or unable to provide written informed consent or comply with subsequent follow-up requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lymph node metastasis fluorescence imaging group	Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging; Injection is performed at the 3 o'clock and 9 o'clock positions of the cervix, with 1 ml on each side, for a total dose of 2 ml. Injection depth: The tracer is injected into the superficial (2 mm) and deep (1 cm) layers, with the superficial injection performed first, followed by the deep injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The sensitivity of lymph node metastasis fluorescence imaging（Signal-to-Background Ratio）.	The time frame was from subject enrollment until surgical pathology results were obtained. The time between subject enrollment and the availability of surgical pathology results was approximately 1 to 1.5 months.

Collaborators and Investigators

• Sponsor: Obstetrics & Gynecology Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Neoplastic Processes; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Neoplasm Metastasis; Uterine Cervical Neoplasms; Lymphatic Metastasis
• Other Study ID Numbers: FUOBGY-2024-224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No