Lateral Neck Lymph Node Mapping in Thyroid Cancer | NCT04312087

Studies
Lateral Neck Lymph Node Mapping in Thyroid Cancer

NCT04312087

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Mar 18, 2020Actual

Enrollment

250Estimated

Phase

Not Applicable

Conditions

Thyroid Cancer

Interventions

Lateral neck sentinel lymph node biopsy
Modified lateral neck lymph node dissection
Super selective lateral neck lymph node dissection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2016Actual

Primary Completion Date

Aug 1, 2021Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Mar 14, 2020

First Submission Date that Met QC Criteria

Mar 16, 2020

First Posted Date

Mar 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2020

Last Update Posted Date

Mar 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 biopsy Procedure: Modified lateral neck lymph node dissection Procedure: Super selective lateral neck lymph node dissection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lateral neck sentinel lymph node biopsy	Procedure	Lateral neck sentinel lymph node biopsy is performed in all patients in Arm B.	SLNB

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu Wang, M.D.	Contact	86-021-64175590	65805	neck130@hotmail.com
Nai-si Huang, M.D.	Contact	86-021-64175590	67816	huangnaisi@fudan.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fudan University Shanghai Cancer Center	Recruiting	Shanghai		200032	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided