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RecruitingNCT06554652Updated Feb 27, 2026

Selective Neck Dissection Versus Modified Neck Dissection in PTC

A Phase 3 interventional study of Lymph node tracer navigated selective neck dissection and Modified neck dissection in Thyroid Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 10 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
14 Years to 80 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Thyroid Cancer

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03

In context

Thyroid Neoplasms

802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.

This study's planned enrollment of 250 is above the median of 51 across 507 interventional studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Selective neck dissection

    Procedure: Lymph node tracer navigated selective neck dissection

  • Active comparator
    Modified neck dissection

    Procedure: Modified neck dissection

Interventions

  • ProcedureLymph node tracer navigated selective neck dissection

    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).

  • ProcedureModified neck dissection

    Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 years

Secondary outcomes

  1. Local-regional Recurrence Rate,LRR

    The percentage of patients with local-regional recurrence in the total number of patients.

    Time frame: 5 years

  2. Progression Free Survival,PFS

    The time from surgery to tumor progression, including local-regional recurrence and distant metastasis.

    Time frame: 5 years

  3. Overall Survival,OS

    The time from surgery to patient death

    Time frame: 5 years

  4. Adverse Events,AE

    The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with surgery.

    Time frame: 5 years

  5. 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).

    Time frame: 5 years

  6. 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.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Fudan Univeristy Shanghai Cancer Center
    Shanghai, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06554652
Lead sponsor
Fudan University
Responsible party
Yu Wang (Chief of Head and Neck Surgery, Fudan University Shanghai Cancer Center, Fudan University) — Principal investigator
First posted
Aug 15, 2024
Start date
Nov 19, 2024
Primary completion
Jun 30, 2029 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Feb 27, 2026

Study contacts

Yu Wang, Dr.
Contact
neck130@sina.com
86-021-64175590 ext. 65805

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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