Lateral Neck Lymph Node Mapping in Thyroid Cancer

Overview

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.

Full Title of Study: “Lateral Neck Lymph Node Mapping in Papillary Thyroid Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1, 2021

Interventions

  • Procedure: Lateral neck sentinel lymph node biopsy
    • Lateral neck sentinel lymph node biopsy is performed in all patients in Arm B.
  • 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: 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).

Arms, Groups and Cohorts

  • Experimental: MLND
    • Modified lateral neck dissection (compartment II-V) is performed in all patients.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Yu Wang, M.D., 86-021-64175590, neck130@hotmail.com

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