Brief Summary

This clinical trial studies how well thyroid lobectomy with ipsilateral central neck dissection works to treat medullary thyroid cancer (MTC) in patients without a germline RET mutation (sporadic). Currently, sporadic and germline RET (rearranged during transfection) mutation positive MTCs that are limited to the thyroid are managed in the same way, complete surgical removal of the entire thyroid gland (total thyroidectomy) with surgical removal of lymph nodes and other tissues on both sides of the neck (bilateral central neck dissection). Total thyroidectomy and bilateral central neck dissection carry a high risk of complications, and total thyroidectomy requires patients to take lifelong thyroid hormone replacement therapy, which can impact quality of life. Research has shown that patients with sporadic MTC do not have a high risk of developing MTC in the remaining normal thyroid tissue and that they may be able to be managed differently than patients with germline RET mutations. Thyroid lobectomy with ipsilateral central neck dissection is a surgical procedure which removes only the lobe of the thyroid gland that is affected by cancer as well as the lymph nodes and other tissues from the affected side of the neck. Thyroid lobectomy with ipsilateral central neck dissection may be a safer, more tolerable, and/or more effective way to treat sporadic MTC.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for not_applicable

Timeline

69mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.6 years study duration

First Submitted

Initial submission to the registry

May 18, 2026

Completed

10 days until next milestone

First Posted

Study publicly available on registry

May 28, 2026

Completed

3 months until next milestone

Study Start

First participant enrolled

September 2, 2026

Expected

5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2031

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2032

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

5 years

First QC Date

May 18, 2026

Last Update Submit

May 27, 2026

Conditions

Thyroid Gland Medullary Carcinoma

Outcome Measures

Primary Outcomes (2)

Proportion of patients who achieve biochemical remission
Will calculate the proportion of patients who achieve biochemical remission at 3 months (normal calcitonin and carcinoembryonic antigen \[CEA\]). Exact 95% confidence intervals will be provided. Exploratory subgroup analyses (e.g., stratified by baseline calcitonin level, tumor size, or nodal status) may be conducted to generate hypotheses but will not be powered for formal inference.
Up to 3 months
Proportion of patients requiring completion thyroidectomy
Completion thyroidectomy will be indicated in the setting of: Elevated or rising calcitonin and/or CEA plus imaging (neck ultrasound or positron emission tomography \[PET\]/computed tomography \[CT\]) suggestive of residual disease in the contralateral thyroid lobe or contralateral cervical lymph nodes; or elevated or rising calcitonin and/or CEA with negative neck ultrasound and PET/CT for an alternate source, consistent with biochemical evidence of residual disease in the remaining thyroid lobe. Exact 95% confidence intervals will be provided. Exploratory subgroup analyses (e.g., stratified by baseline calcitonin level, tumor size, or nodal status) may be conducted to generate hypotheses but will not be powered for formal inference.
Up to 12 months

Secondary Outcomes (2)

Short-term oncologic outcomes
At 12 months
Prevalence of occult contralateral disease
Perioperative/Periprocedural

Study Arms (1)

Treatment (thyroid lobectomy, unilateral neck dissection)

EXPERIMENTAL

Patients undergo thyroid lobectomy with unilateral central neck dissection on study. Patients then undergo blood sample collection for calcitonin and CEA monitoring with neck ultrasound and/or Ga-68 or FDG PET/CT at 3 and 6 month follow-ups. Patients with no biochemical or imaging evidence of persistent disease undergo routine cancer surveillance. Patients with either of the following: 1) Elevated or rising calcitonin and/or CEA plus imaging suggestive of residual disease in the contralateral thyroid lobe or contralateral cervical lymph nodes, or 2) Elevated or rising calcitonin and/or CEA with negative imaging for an alternate source, consistent with biochemical evidence of residual disease in the remaining thyroid lobe, may undergo completion thyroidectomy and/or contralateral neck dissection during follow up. Patients also undergo additional blood sample collection, neck ultrasound, and/or Ga-68 or FDG PET/CT throughout the study.

Procedure: Biospecimen CollectionProcedure: FDG-Positron Emission Tomography and Computed Tomography ScanProcedure: Ga-68 PET/CT ScanProcedure: Neck DissectionBehavioral: SurveillanceProcedure: Thyroid LobectomyProcedure: ThyroidectomyProcedure: Ultrasound Imaging

Interventions

Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection