Thyroid CancerPhase 3NCT06554652
Selective Neck Dissection Versus Modified Neck Dissection in PTC
A Phase 3 study testing Lymph node tracer navigated selective neck dissection and Modified neck dissection in people with Thyroid Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is a phase III, randomized controlled, open label non inferiority study. Patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with LRFS as the primary endpoint. 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?
- Lymph node tracer navigated selective neck dissection and Modified neck dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 19 Nov 2024to 30 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Pathologically confirmed PTC;
- Age range: 14-80 years old;
- Preoperative fine needle aspiration confirms lymph node metastasis in the lateral neck
- Ultrasound and CT suggest that metastatic/suspected metastatic lymph nodes are limited to compartment IV, with 1-2 lymph node metastases and <1cm in short diameter. The lymph nodes have no central necrosis, liquefaction, peripheral enhancement, or disappearance of adjacent fat spaces (predicting unobstructed lymphatic vessels);
- Thyroid tumors without extra thyroidal extension;
- Enough thyroid volume to inject tracer.
Who cannot join
- Previous neck surgery;
- Bilateral neck lymph node dissection;
- Distant metastases;
- High risk pathological subtypes or the presence of other high-risk factors for recurrence;
- Previous treatment for thyroid cancer other than endocrine therapy;
- The patient is unable to cooperate with follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan Univeristy Shanghai Cancer Center
Shanghai
Yu Wang, M.D., 86-021-64175590 ext. 65805, neck130@hotmail.com
About this study
Official title: Tracer Navigated Selective Neck Dissection Versus Modified Neck Dissection in Papillary Thyroid Cancer With Limited Lymph Node Metastasis in the Lateral Neck: A Randomized, Noninferiority Phase III Trial
This study is a phase III, randomized controlled, open label non inferiority study. Patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with LRFS as the primary endpoint. The aim of the study is to evaluate the safety of selective neck dissection in papillary carcinoma with limited number of lymph node metastases in the lateral neck, and the quality of life compared with modified neck dissection.
- Conditions
- Thyroid Cancer
- Being tested
- Lymph node tracer navigated selective neck dissection, Modified neck dissection
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymph node tracer navigated selective neck dissectionProcedure or surgery
Selective lateral lymph node dissection (after injection of tracer, lymph nodes in compartment III-IV are dissected; if there is dyed lymph node in compartment IIA, then IIA is dissected).
Modified neck dissectionProcedure or surgery
Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected.
| Study group | Role | What they receive |
|---|---|---|
| Selective neck dissection | Experimental | Not described Receives: Procedure: Lymph node tracer navigated selective neck dissection |
| Modified neck dissection | Active comparator | Not described Receives: Procedure: Modified neck dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local-regional Recurrence Free Survival，LRFS
The time from surgery to the recurrence based on RECIST 1.1,. The definition of local-regional areas includes thyroid area, cervical I-VII lymph nodes, and retropharyngeal lymph nodes.
Measured: 5 years
Secondary outcomes (6)
Local-regional Recurrence Rate，LRR
The percentage of patients with local-regional recurrence in the total number of patients.
Measured: 5 years
Progression Free Survival，PFS
The time from surgery to tumor progression, including local-regional recurrence and distant metastasis.
Measured: 5 years
Overall Survival，OS
The time from surgery to patient death
Measured: 5 years
Adverse Events，AE
The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with surgery.
Measured: 5 years
Quality of Life as assessed by UW-QOL V4.1
Quality of life assessments will be conducted at 1 week, 3 months, 1 year, 2 years, and 5 years after surgery. The QoL evaluation scale adopts the Washington University Quality of Life Questionnaire V4.1 (UW-QOL V4.1).
Measured: 5 years
Quality of Life as assessed by QoL/Thyroid
Quality of life assessments will be conducted at 1 week, 3 months, 1 year, 2 years, and 5 years after surgery. The QoL evaluation scale adopts the Thyroid Cancer Quality of Life Scale QoL/Thyroid.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start19 Nov 2024
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (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 3
- Primary purpose
- Treatment
- Allocation
- 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
- Principal investigator, Yu Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554652
- Sponsor's protocol ID
- SELECTION
- Status last verified
- Feb 2026
- First submitted
- 27 Jul 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracer Navigated Selective Neck Dissection Versus Modified Neck Dissection in Papillary Thyroid Cancer With Limited Lymph Node Metastasis in the Lateral Neck: A Randomized, Noninferiority Phase III Trial
- ClinicalTrials.gov ID
- NCT06554652
- Acronym / sponsor ID
- SELECTION
- Conditions
- Thyroid Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 15 Aug 2024 (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 is a phase III, randomized controlled, open label non inferiority study. Patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with LRFS as the primary endpoint. The aim of the study is to evaluate the safety of selective neck dissection in papillary carcinoma with limited number of lymph node metastases in the lateral neck, and the quality of life compared with modified neck dissection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selective neck dissection | Experimental | Procedure: Lymph node tracer navigated selective neck dissection |
| Modified neck dissection | Active comparator | Procedure: Modified neck dissection |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Pathologically confirmed PTC;
- Age range: 14-80 years old;
- Preoperative fine needle aspiration confirms lymph node metastasis in the lateral neck
- Ultrasound and CT suggest that metastatic/suspected metastatic lymph nodes are limited to compartment IV, with 1-2 lymph node metastases and <1cm in short diameter. The lymph nodes have no central necrosis, liquefaction, peripheral enhancement, or disappearance of adjacent fat spaces (predicting unobstructed lymphatic vessels);
- Thyroid tumors without extra thyroidal extension;
Key exclusion criteria (6 listed)
- Previous neck surgery;
- Bilateral neck lymph node dissection;
- Distant metastases;
- High risk pathological subtypes or the presence of other high-risk factors for recurrence;
- Previous treatment for thyroid cancer other than endocrine therapy;
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 |
|---|---|---|
| Lymph node tracer navigated selective neck dissectionSelective lateral lymph node dissection (after injection of tracer, lymph nodes in compartment III-IV are dissected; if there is dyed lymph node in compartment IIA, then IIA is dissected). | Procedure or surgery | Selective neck dissection |
| Modified neck dissectionLymph nodes in compartment IIA, IIB, III, IV, VB are dissected. | Procedure or surgery | Modified neck dissection |
Primary outcome
Local-regional Recurrence Free Survival，LRFS
Time frame: 5 years
The time from surgery to the recurrence based on RECIST 1.1,. The definition of local-regional areas includes thyroid area, cervical I-VII lymph nodes, and retropharyngeal lymph nodes.
6 secondary outcomes
Local-regional Recurrence Rate，LRR
Time frame: 5 years
Progression Free Survival，PFS
Time frame: 5 years
Overall Survival，OS
Time frame: 5 years
Adverse Events，AE
Time frame: 5 years
Quality of Life as assessed by UW-QOL V4.1
Time frame: 5 years
Quality of Life as assessed by QoL/Thyroid
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lymph node tracer navigated selective neck dissection and Modified neck 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Wang, Dr. (86-021-64175590 ext. 65805, neck130@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local-regional Recurrence Free Survival，LRFS (time frame: 5 years). 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 27 Feb 2026.