Lateral Neck Lymph Node Mapping in Thyroid Cancer

NCT ID: NCT04312087

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Thyroid Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MLND

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

Group Type EXPERIMENTAL

Modified lateral neck lymph node dissection

Intervention Type PROCEDURE

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).

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.

Group Type EXPERIMENTAL

Lateral neck sentinel lymph node biopsy

Intervention Type PROCEDURE

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

Modified lateral neck lymph node dissection

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Interventions

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Lateral neck sentinel lymph node biopsy

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

Intervention Type 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).

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu Wang, M.D.

Role: CONTACT

86-021-64175590 ext. 65805

Nai-si Huang, M.D.

Role: CONTACT

86-021-64175590 ext. 67816

Facility Contacts

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Yu Wang, M.D.

Role: primary

86-021-64175590 ext. 65805

Other Identifiers

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TC-MAP

Identifier Type: -

Identifier Source: org_study_id

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