Lateral Neck Lymph Node Mapping in Thyroid Cancer

Not Applicable

• Conditions: Thyroid Cancer

• Registration Number: NCT04312087
• Lead Sponsor: Fudan University

Brief Summary

This study includes papillary thyroid cancer patients who have unpalpable lateral neck lymph nodes but suspicious on ultrasound and/or CT. Carbon nanoparticles is used as the tracer for lateral neck lymph node mapping.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Status Verified: 2020-03
• Study First Submitted: 2020-03-14
• Study First Submitted QC: 2020-03-16
• Last Update Submitted: 2020-03-16
• Study First Posted: 2020-03-18
• Last Update Posted: 2020-03-18
• Primary Completion: 2021-08-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Newly diagnosed papillary thyroid cancer
• The maximum diameter of the thyroid cancer <3 cm with enough normal thyroid tissue for tracer injection
• Unpalpable lateral neck lymph nodes
• Ultrasound and CT showed suspected lateral neck lymph nodes <2 cm

Exclusion Criteria

• Previously treated thyroid cancer
• High risk thyroid cancer (e.g. with severe extra-adenial invasion or extensive lymph node metastasis or poorly differentiated thyroid cancer)
• Patients with distant metastasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lymph node counts	1 month after surgery	Dyed versus undyed lymph node counts in lateral neck compartments

Secondary Outcome Measures

Name	Time	Method
Lymph node metastasis rate	1 month after surgery	The rate of lymph node metastasis in lateral neck compartments

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China