STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Male or female ≥ 18 years of age at time of diagnosis

Thyroid fine needle aspiration biopsy with cytologist consistent with medullary thyroid cancer

Indeterminate cytology from thyroid fine needle aspiration with elevated serum calcitonin OR thyroid molecular testing consistent with medullary thyroid cancer

Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study

Disqualifiers

Graves' disease

Symptomatic multinodular goiter

Contralateral symptomatic benign nodules

Cervical lymphadenopathy involving lateral neck or contralateral central neck

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • FDG-Positron Emission Tomography and Computed Tomography Scan
  • Ga-68 PET/CT Scan
  • Neck Dissection
  • Neck Dissection
  • Surveillance
  • Thyroid Lobectomy
  • Thyroidectomy
  • Ultrasound Imaging

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

Jonsson Comprehensive Cancer Center

Lead sponsor

Eli Lilly and Company

Collaborator