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Thyroid Gland Medullary CarcinomaNCT07612293

STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection

A study testing Biospecimen Collection, FDG-Positron Emission Tomography and Computed Tomography Scan and Ga-68 PET/CT Scan in people with Thyroid Gland Medullary Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Gland Medullary Carcinoma
What is being tested?
Biospecimen Collection, FDG-Positron Emission Tomography and Computed Tomography Scan and Ga-68 PET/CT Scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
2 Sep 2027to 2 Sep 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female ≥ 18 years of age at time of diagnosis
  • Documentation of a medullary thyroid cancer diagnosis as evidenced by:
  • 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
  • Appropriate candidate for thyroid lobectomy and/or total thyroidectomy

Who cannot join

  • Indication for total thyroidectomy unrelated to medullary thyroid cancer:
  • Graves' disease
  • Symptomatic multinodular goiter
  • Contralateral symptomatic benign nodules
  • Ultrasound findings consistent with:
  • Cervical lymphadenopathy involving lateral neck or contralateral central neck
Show all 10Show fewer
  • Suspicious thyroid nodules > 1 cm that are Thyroid Imaging Reporting and Data Systems 2 (TIRADS2) or higher without fine needle aspiration (FNA)
  • Pure cystic and spongiform nodules do not require FNA
  • Patients with nodules that meet criteria above can elect to undergo FNA, and may enroll in study if benign cytology is noted
  • Identification of germline RET mutation on preoperative genetic testing

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elena Hughes contact

310 206-9145

EGHughes@mednet.ucla.edu

United States1 site

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

    Elena Hughes, 310-206-9145, eghughes@mednet.ucla.edu

    James Wu, MD

Other trials in United States

About this study

Official title: STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection for the Treatment of Sporadic Medullary Thyroid Cancer, STAGE-MTC 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the number of patients that have no biochemical evidence of persistent medullary thyroid cancer following thyroid lobectomy and ipsilateral prophylactic central neck dissection alone versus number of patients with biochemical evidence of persistent MTC that requires completion thyroidectomy.

SECONDARY OBJECTIVES:

  1. Determine the short-term oncologic treatment outcomes of a novel staged approach to sporadic medullary thyroid cancer, defined by response to therapy category (excellent, biochemical incomplete, structural incomplete).

II. Determine the prevalence of undetected foci of medullary thyroid cancer in contralateral thyroid lobe and contralateral lymph nodes.

OUTLINE:

Patients undergo thyroid lobectomy with unilateral central neck dissection on study. Patients then undergo blood sample collection for calcitonin and carcinoembryonic antigen (CEA) monitoring with neck ultrasound and/or gallium-68 (Ga-68) or fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/computed tomography (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.

After completion of study intervention, patients are followed up at day 14 and months 3, 6, 12, 18, and 24.

Being tested
Biospecimen Collection, FDG-Positron Emission Tomography and Computed Tomography Scan, Ga-68 PET/CT Scan, Neck Dissection, Surveillance
Medical subject headings
Carcinoma, Medullary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • FDG-Positron Emission Tomography and Computed Tomography ScanProcedure or surgery

    Also called FDG PET/CT

    Undergo FDG PET/CT

  • Ga-68 PET/CT ScanProcedure or surgery

    Also called Gallium-68 PET/CT Scan, Gallium-68 Positron Emission Tomography and Computed Tomography Scan

    Undergo Ga-68 PET/CT

  • Neck DissectionProcedure or surgery

    Undergo unilateral central neck dissection

  • Neck DissectionProcedure or surgery

    Undergo contralateral neck dissection

  • SurveillanceBehavioural

    Also called Epidemiology / Surveillance

    Undergo routine cancer surveillance

  • Thyroid LobectomyProcedure or surgery

    Also called Lobectomy of Thyroid Gland, Unilateral Thyroid Lobectomy

    Undergo thyroid lobectomy

  • ThyroidectomyProcedure or surgery

    Undergo completion thyroidectomy

  • Ultrasound ImagingProcedure or surgery

    Also called 2-Dimensional Grayscale Ultrasound Imaging, 2-Dimensional Ultrasound Imaging, 2D-US, Ultrasonography

    Undergo neck ultrasound

Study groups in NCT07612293
Study groupRoleWhat they receive
Treatment (thyroid lobectomy, unilateral neck dissection)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan; Procedure: Ga-68 PET/CT Scan; Procedure: Neck Dissection; Behavioral: Surveillance; Procedure: Thyroid Lobectomy; Procedure: Thyroidectomy; Procedure: Ultrasound Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 3 months

  2. 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.

    Measured: Up to 12 months

Secondary outcomes (2)

  1. Short-term oncologic outcomes

    Short-term oncologic outcomes will be categorized according to the American Thyroid Association ATA) "response to therapy" framework, adapted for medullary thyroid carcinoma. Categories will include: Excellent response: Normal calcitonin and CEA with no structural evidence of disease on imaging; Biochemical incomplete response: Abnormal calcitonin and/or CEA without structural evidence of disease; Structural incomplete response: Evidence of structural disease on imaging, regardless of biochemical status. Will be summarized descriptively. Exact 95% confidence intervals will be reported. Comparisons to baseline disease features (e.g., initial calcitonin levels, tumor size, lymph node involvement) may be explored but will be considered hypothesis-generating only.

    Measured: At 12 months

  2. Prevalence of occult contralateral disease

    Among patients who undergo completion thyroidectomy and/or contralateral neck dissection, will assess the prevalence of previously undetected foci of medullary thyroid cancer in the contralateral thyroid lobe and contralateral cervical lymph nodes. Pathologic findings will be reported as proportions with corresponding exact 95% confidence intervals.

    Measured: Perioperative/Periprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study start2 Sep 2027 (estimated)
  3. Primary completion2 Sep 2032 (estimated)
  4. Study completion2 Sep 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07612293
Sponsor's protocol ID
25-0553
Other IDs
NCI-2026-03211
Status last verified
May 2026
First submitted
18 May 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Biospecimen Collection, FDG-Positron Emission Tomography and Computed Tomography Scan and Ga-68 PET/CT Scan in people with Thyroid Gland Medullary Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elena Hughes (310 206-9145, EGHughes@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who achieve biochemical remission (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07612293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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