Back to resultsLateral Neck Lymph Node Mapping in Thyroid Cancer
Primary Purpose
Thyroid Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lateral neck sentinel lymph node biopsy
Modified lateral neck lymph node dissection
Super selective lateral neck lymph node dissection
Sponsored by
About this trial
This is an interventional other trial for Thyroid Cancer focused on measuring thyroid cancer, lateral neck lymph node, lymph node mapping, neck dissection, sentinel lymph node
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
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MLND
SLNB
Arm Description
Modified lateral neck dissection (compartment II-V) is performed in all patients.
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.
Outcomes
Primary Outcome Measures
Lymph node counts
Dyed versus undyed lymph node counts in lateral neck compartments
Secondary Outcome Measures
Lymph node metastasis rate
The rate of lymph node metastasis in lateral neck compartments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04312087
Brief Title
Lateral Neck Lymph Node Mapping in Thyroid Cancer
Official Title
Lateral Neck Lymph Node Mapping in Papillary Thyroid Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
thyroid cancer, lateral neck lymph node, lymph node mapping, neck dissection, sentinel lymph node
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MLND
Arm Type
Experimental
Arm Description
Modified lateral neck dissection (compartment II-V) is performed in all patients.
Arm Title
SLNB
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lateral neck sentinel lymph node biopsy
Intervention Description
Lateral neck sentinel lymph node biopsy is performed in all patients in Arm B.
Intervention Type
Procedure
Intervention Name(s)
Modified lateral neck lymph node dissection
Intervention Description
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
Intervention Name(s)
Super selective lateral neck lymph node dissection
Intervention Description
Super selective lateral neck lymph node dissection is performed in some of the patients in Arm B (according to sentinel lymph node biopsy results).
Primary Outcome Measure Information:
Title
Lymph node counts
Description
Dyed versus undyed lymph node counts in lateral neck compartments
Time Frame
1 month after surgery
Secondary Outcome Measure Information:
Title
Lymph node metastasis rate
Description
The rate of lymph node metastasis in lateral neck compartments
Time Frame
1 month after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Wang, M.D.
Phone
86-021-64175590
Ext
65805
Email
neck130@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nai-si Huang, M.D.
Phone
86-021-64175590
Ext
67816
Email
huangnaisi@fudan.edu.cn
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Wang, M.D.
Phone
86-021-64175590
Ext
65805
Email
neck130@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lateral Neck Lymph Node Mapping in Thyroid Cancer
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