New scan spots hidden thyroid tumors that resist standard treatment
NCT ID NCT04927416
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 12 times
Summary
This study tests whether a special PET scan using a radioactive tracer called 68Gallium-DOTATATE can better detect thyroid cancer that has spread and no longer responds to standard radioactive iodine therapy. About 54 adults with metastatic thyroid cancer will receive one injection of the tracer and undergo a PET/CT scan. The goal is to see how many participants have tumors that light up on the scan, which could guide future treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 68Gallium-DOTATATE (a radioactive tracer for PET/CT scans)
- What this could lead to
- If successful, this imaging method could help doctors identify which thyroid cancer patients might benefit from treatments targeting a specific tumor marker (SSTR2).
- What could go wrong
- This is a small, early-phase imaging study, not a treatment trial. It may not lead to direct patient benefits, and the tracer's ability to improve outcomes is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Nov 2030
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 98 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Data prospectively collected from the 28 subjects enrolled under this protocol, and data from 26 subjects collected under 77-DK-0096 and/or 00-CH-0093 will be analyzed. Among the 26 subjects prospectively evaluated under 77-DK-0096 protocol, 21 out of 26 had research 68Ga-DOTATATE PET/CT performed under the DOTATATE sub-study of 77-DK-0096, and 5 out of 26 had 68Ga-DOTATATE PET/CT done under 00-CH-0093. Again, the inclusion of the above data was per the IRB s request to transition the sub-study into a new standalone protocol. This will give us a total of 54 subjects for the final analyses, with at least 18 subjects from each group (e.g., HTC, DTC, and MTC), which is required to meet the primary objectives of this study with sufficient power of 80% and type 1 error alpha of \< 0.05. Patients with HTC, DTC, and MTC will be identified by the investigators. The potential candidates for the study will be screened for eligibility to participate in the study and invited to sign the Research 68Ga-DOTATATE PET/CT imaging informed consent form. The same inclusion/exclusion criteria were applied to the subjects who underwent imaging with the 68GADOTATATE PET/CT, either under the 77-DK-0096 sub-study or as clinically-indicated imaging under 00-CH-0093. In order to be eligible to participate in this study, an individual with DTC (including HTC) must meet all of the following criteria: * Male or female, aged \>18 years. * Patients with established thyroid cancer diagnosis presenting with either: * Locally advanced or distant metastases, which are RAI-non-avid based on the or diagnostic or post-treatment whole body scan (WBS) OR --Patients with RAI-non-responsive disease, who have the evidence of disease progression defined by RECIST 1.1 criteria after therapy with RAI. In order to be eligible to participate in this study, an individual with MTC must meet all of the following criteria: * Male or female, aged \>18 years. * Patients with locally advanced or metastatic MTC or patients suspected of locally advanced or metastatic MTC with calcitonin level \> 500 pg/mL. EXCLUSION CRITERIA: Subjects with either HTC, DTC, or MTC who meet any of the following criteria will be excluded from participation in this study: * Pregnancy or lactation by self-report. * Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma; * Patients unable to give informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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- Boosting thyroid cancer therapy: does rhTSH make radioactive iodine more effective?
- Could being male or female change how a thyroid cancer drug works?