STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT07612293
Status
Not Yet Recruiting

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Conditions

  • Thyroid Gland Medullary Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • FDG-Positron Emission Tomography and Computed Tomography Scan — PROCEDURE
    Undergo FDG PET/CT
  • Ga-68 PET/CT Scan — PROCEDURE
    Undergo Ga-68 PET/CT
  • Neck Dissection — PROCEDURE
    Undergo unilateral central neck dissection
  • Neck Dissection — PROCEDURE
    Undergo contralateral neck dissection
  • Surveillance — BEHAVIORAL
    Undergo routine cancer surveillance
  • Thyroid Lobectomy — PROCEDURE
    Undergo thyroid lobectomy
  • Thyroidectomy — PROCEDURE
    Undergo completion thyroidectomy
  • Ultrasound Imaging — PROCEDURE
    Undergo neck ultrasound

Study Details

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.

Key Dates

Start date
Sep 2, 2026
Status verified
May 2026
Primary completion
Sep 2, 2031
Completion
Apr 21, 2032

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (thyroid lobectomy, unilateral neck dissection)
    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.

Primary Outcome Measure

Proportion of patients who achieve biochemical remission [ Time Frame: Up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Elena Hughes
[email protected]
310-206-9145
James Wu, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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