Thyroid CancerNCT04312087
Lateral Neck Lymph Node Mapping in Thyroid Cancer
A study testing Lateral neck sentinel lymph node biopsy, Modified lateral neck lymph node dissection and Super selective lateral neck lymph node dissection in people with Thyroid Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Lateral neck sentinel lymph node biopsy, Modified lateral neck lymph node dissection and Super selective lateral neck lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2016to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Yu Wang, M.D., 86-021-64175590 ext. 65805, neck130@hotmail.com
About this study
Official title: Lateral Neck Lymph Node Mapping in Papillary Thyroid Carcinoma
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.
- Conditions
- Thyroid Cancer
- Being tested
- Lateral neck sentinel lymph node biopsy, Modified lateral neck lymph node dissection, Super selective lateral neck lymph node dissection
- Keywords
- thyroid cancer, lateral neck lymph node, lymph node mapping, neck dissection, sentinel lymph node
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral neck sentinel lymph node biopsyProcedure or surgery
Lateral neck sentinel lymph node biopsy is performed in all patients in Arm B.
Modified lateral neck lymph node dissectionProcedure or surgery
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 dissectionProcedure or surgery
Super selective lateral neck lymph node dissection is performed in some of the patients in Arm B (according to sentinel lymph node biopsy results).
| Study group | Role | What they receive |
|---|---|---|
| MLND | Experimental | Modified lateral neck dissection (compartment II-V) is performed in all patients. Receives: 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. Receives: Procedure: Lateral neck sentinel lymph node biopsy; Procedure: Modified lateral neck lymph node dissection; Procedure: Super selective lateral neck lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node counts
Dyed versus undyed lymph node counts in lateral neck compartments
Measured: 1 month after surgery
Secondary outcomes (1)
Lymph node metastasis rate
The rate of lymph node metastasis in lateral neck compartments
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Aug 2016
- Primary completion1 Aug 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312087
- Sponsor's protocol ID
- TC-MAP
- Status last verified
- Mar 2020
- First submitted
- 14 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Neck Lymph Node Mapping in Papillary Thyroid Carcinoma
- ClinicalTrials.gov ID
- NCT04312087
- Acronym / sponsor ID
- TC-MAP
- Conditions
- Thyroid Cancer
- Keywords
- thyroid cancer, lateral neck lymph node, lymph node mapping, neck dissection, sentinel lymph node
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MLND | Experimental | Procedure: Modified lateral neck lymph node dissectionModified lateral neck dissection (compartment II-V) is performed in all patients. |
| SLNB | Experimental | Procedure: Lateral neck sentinel lymph node biopsy, Procedure: Modified lateral neck lymph node dissection, Procedure: Super selective lateral neck lymph node dissectionSentinel lymph node biopsy in the lateral neck is performed. The decision of neck dissection is based on the result of sentinel lymph node biopsy. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral neck sentinel lymph node biopsyLateral neck sentinel lymph node biopsy is performed in all patients in Arm B. | Procedure or surgery | SLNB |
| Modified lateral neck lymph node dissectionModified 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 or surgery | MLND, SLNB |
| Super selective lateral neck lymph node dissectionSuper selective lateral neck lymph node dissection is performed in some of the patients in Arm B (according to sentinel lymph node biopsy results). | Procedure or surgery | SLNB |
Primary outcome
Lymph node counts
Time frame: 1 month after surgery
Dyed versus undyed lymph node counts in lateral neck compartments
1 secondary outcome
Lymph node metastasis rate
Time frame: 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral neck sentinel lymph node biopsy, Modified lateral neck lymph node dissection and Super selective lateral neck lymph node dissection in people with Thyroid Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Wang, M.D. (86-021-64175590 ext. 65805, neck130@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph node counts (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020; AzTrials last refreshed its copy on 27 Oct 2026.