NCT04312087

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

5 years

First QC Date

March 14, 2020

Last Update Submit

March 16, 2020

Conditions

Thyroid Cancer

Keywords

thyroid cancerlateral neck lymph nodelymph node mappingneck dissectionsentinel lymph node

Outcome Measures

Primary Outcomes (1)

  • Lymph node counts

    Dyed versus undyed lymph node counts in lateral neck compartments

    1 month after surgery

Secondary Outcomes (1)

  • Lymph node metastasis rate

    1 month after surgery

Study Arms (2)

MLND

EXPERIMENTAL

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

Procedure: Modified lateral neck lymph node dissection

SLNB

EXPERIMENTAL

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: Lateral neck sentinel lymph node biopsyProcedure: Modified lateral neck lymph node dissectionProcedure: Super selective lateral neck lymph node dissection

Interventions

Lateral neck sentinel lymph node biopsyPROCEDURE

Lateral neck sentinel lymph node biopsy is performed in all patients in Arm B.

SLNB
Modified lateral neck lymph node dissectionPROCEDURE

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).

MLNDSLNB
Super selective lateral neck lymph node dissectionPROCEDURE

Super selective lateral neck lymph node dissection is performed in some of the patients in Arm B (according to sentinel lymph node biopsy results).

SLNB

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Yu Wang, M.D.

CONTACT

86-021-64175590neck130@hotmail.com

Nai-si Huang, M.D.

CONTACT

86-021-64175590huangnaisi@fudan.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2020

First Posted

March 18, 2020

Study Start

August 1, 2016

Primary Completion

August 1, 2021

Study Completion

December 31, 2022

Last Updated

March 18, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)