Selective versus modified neck dissection for papillary thyroid cancer

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 tests whether removing only selected lateral neck lymph nodes (selective neck dissection) gives similar cancer control but better quality of life than a more extensive modified neck dissection for people with papillary thyroid cancer who have 1–2 small metastatic nodes in the lateral neck.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 14 Years to 80 Years
• Sex: All
• Sponsor: Fudan University (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06554652 on ClinicalTrials.gov

What this trial studies

This is a phase III, open-label, randomized non-inferiority trial that assigns eligible patients 1:1 to lymph node tracer–navigated selective neck dissection or to modified neck dissection. The main outcome is lateral recurrence-free survival (LRFS); safety and patient-reported quality of life are also compared. Eligible patients have pathologically confirmed papillary thyroid carcinoma with 1–2 suspected metastatic nodes limited to compartment IV, each under 1 cm, no extrathyroidal extension, and sufficient thyroid volume for tracer injection. The study is conducted at Fudan University Shanghai Cancer Center using tracer navigation to guide selective node removal and standard techniques for modified dissection.

Who should consider this trial

Good fit: Ideal candidates are patients aged 14–80 with pathologically confirmed papillary thyroid carcinoma and preoperative confirmation of 1–2 metastatic lateral neck nodes limited to compartment IV, under 1 cm, without extrathyroidal extension or prior neck surgery and with sufficient thyroid volume for tracer injection.

Not a fit: Patients with multiple or larger lateral nodes, central necrosis or liquefaction, extrathyroidal extension, distant metastases, high‑risk histology, prior neck surgery, bilateral neck disease, or inability to follow up are unlikely to benefit from selective dissection and may require more extensive treatment.

Why it matters

Potential benefit: If successful, the selective approach could maintain similar cancer control while preserving more neck function and improving postoperative quality of life.

How similar studies have performed: Observational and sentinel-node studies of selective or limited neck dissection have shown promising safety and functional benefits, but randomized phase III non-inferiority evidence is limited.

Eligibility criteria

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:

* 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.

Where this trial is running

Shanghai

• Fudan Univeristy Shanghai Cancer Center — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Yu Wang, Dr.

Conditions: Thyroid Cancer