Lateral Neck Lymph Node Mapping in Thyroid Cancer

Thyroid Cancer Clinical Trial

Official title:

Lateral Neck Lymph Node Mapping in Papillary Thyroid Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04312087
• Other study ID #: TC-MAP
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2020
• Source: Fudan University
• Contact: Yu Wang, M.D.
• Phone: 86-021-64175590
• Email: neck130[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• Lateral neck sentinel lymph node biopsy
Lateral neck sentinel lymph node biopsy is performed in all patients in Arm B.
• Modified lateral neck lymph node dissection
Modified lateral neck dissection (compartment II-V) is performed in all patients in Arm A, and some of the patients in Arm B (according to sentinel lymph node biopsy results).
• Super selective lateral neck lymph node dissection
Super selective lateral neck lymph node dissection is performed in some of the patients in Arm B (according to sentinel lymph node biopsy results).

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymph node counts	Dyed versus undyed lymph node counts in lateral neck compartments	1 month after surgery
Secondary	Lymph node metastasis rate	The rate of lymph node metastasis in lateral neck compartments	1 month after surgery