Lateral Neck Lymph Node Mapping in Thyroid Cancer

March 16, 2020 updated by: Fudan University

Lateral Neck Lymph Node Mapping in Papillary Thyroid Carcinoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MLND
Modified lateral neck dissection (compartment II-V) is performed in all patients.
Procedure: 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).
Experimental: SLNB
Sentinel lymph node biopsy in the lateral neck is performed. The decision of neck dissection is based on the result of sentinel lymph node biopsy.
Procedure: 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).
Procedure: Lateral neck sentinel lymph node biopsy
Lateral neck sentinel lymph node biopsy is performed in all patients in Arm B.
Procedure: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymph node counts
Time Frame: 1 month after surgery
Dyed versus undyed lymph node counts in lateral neck compartments
1 month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymph node metastasis rate
Time Frame: 1 month after surgery
The rate of lymph node metastasis in lateral neck compartments
1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

March 14, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC-MAP

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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