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

Lymph Node Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06399159
• Other study ID #: Review-2023-109
• Status: Completed
• Start date: September 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: Nanchong Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Lymph Node Metastasis
• Lymphatic Metastasis
• Neoplasm Metastasis
• Papillary Thyroid Carcinoma
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Nanchong central hospital	Nanchong	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Nanchong Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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