Prediction of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma Based on Ultrasound and Cytological Images

An Interpretable Multimodal Model Based on Cytology Ultrasound Noninvasively Predicts Lymph Node Metastasis in cN0 Papillary Thyroid Cancer

Rising thyroid carcinoma rates, with papillary thyroid carcinoma (PTC) as the main type (85-90% of cases), often show early cervical lymph node spread. This increases the risk of PTC patients for recurrence and death. A new study's multimodal model fuses preoperative US and cytology images to better predict lymph node metastasis, aiming to improve treatment plans, reduce unnecessary surgeries, and enhance patient outcomes.

Study Overview

• Status: Completed
• Conditions: Papillary Thyroid Carcinoma; Lymph Node Metastasis
• Intervention / Treatment: Procedure: Thyroidectomy and lymph node dissection

Detailed Description

Thyroid carcinoma incidence has been on the rise in recent years. Papillary thyroid carcinoma is the most prevalent type of differentiated thyroid carcinoma, accounting for 85% to 90% of malignant thyroid tumors. Despite its indolent nature, cervical lymph node metastasis is frequently observed at an early stage. Papillary thyroid carcinoma patients with cervical lymph node metastasis face an elevated risk of recurrence, distant metastasis, and mortality. Thus, non-invasive preoperative prediction of cervical lymph node metastasis is particularly vital for guiding treatment plans and prognostic. this study has developed a multimodal model integrating preoperative US images with cytological images of papillary thyroid carcinoma patients. The aim is to enhance the predictive accuracy for cervical lymph node metastasis, reduce unnecessary lymph node dissections, and provide real-time, precise guidance for determining the extent of surgical resection and prognostic assessment. This approach aims to optimize patient treatment strategies and enhance therapeutic outcomes.

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Nanchong, Sichuan, China, 637000
      • Nanchong Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with papillary thyroid cancer from ten hospitals in China

Description

Inclusion Criteria:

• Underwent thyroidectomy and bilateral lymph node dissection with pathological confirmation of PTC
• Completed US examination within one week before surgery
• Underwent preoperative us-guided FNAC
• Completed cytological images at 400× magnification under a microscope

Exclusion Criteria:

• Patients who underwent only unilateral thyroidectomy
• Patients with cervical lymph nodes shown on preoperative ultrasound

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort with Lymph Node Metastasis; Depending on the pathological findings, it is classified as the presence of lymph node metastases.	Procedure: Thyroidectomy and lymph node dissection; All surgical specimens of thyroidectomy and lymph node dissection were subjected to paraffin-embedded histopathological examination, and postoperative were categorized as with cervical lymph node metastasis and without cervical lymph node metastasis.
Cohort without Lymph Node Metastasis; Depending on the pathological findings, it is classified as the absence of lymph node metastases.	Procedure: Thyroidectomy and lymph node dissection; All surgical specimens of thyroidectomy and lymph node dissection were subjected to paraffin-embedded histopathological examination, and postoperative were categorized as with cervical lymph node metastasis and without cervical lymph node metastasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of lymph node metastasis	All surgical specimens were subjected to paraffin-embedded histopathological examination，depending on the pathological findings, it is classified as the presence or absence of lymph node metastases.	October 2024

Collaborators and Investigators

• Sponsor: Nanchong Central Hospital
• Investigators: Study Chair: Xiachuan Qin, MD, Nanchong Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound; deep learning; cytology
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Neoplastic Processes; Adenocarcinoma, Papillary; Carcinoma; Neoplasm Metastasis; Thyroid Diseases; Lymphatic Metastasis; Thyroid Neoplasms; Thyroid Cancer, Papillary
• Other Study ID Numbers: Review-2023-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No