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68-Gallium-DOTATATE-PET/CT Imaging for Metastatic Thyroid Cancer

This study is looking at a special imaging test called 68-Gallium-DOTATATE-PET/CT for people with thyroid cancer that has spread (metastatic) and is resistant to standard radioactive iodine treatment. Researchers want to see if this test can help find thyroid tumors better. The 68-Gallium-DOTATATE compound attaches to certain cells in the tumor, making it visible on the PET/CT scan. This information could help doctors understand which patients might benefit from future treatments. You may be able to join if you are 18 or older and have metastatic thyroid cancer. The main goal is to see how many patients have tumors that show a high uptake of 68-Gallium-DOTATATE during the scan. The study status is currently unclear.

Study design
This is an interventional study planning to enroll 54 participants. It involves a one-time experimental imaging procedure.
What's involved
Participants will receive a single intravenous injection of 68-Gallium-DOTATATE and undergo a PET/CT scan.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured during a baseline assessment, so long-term follow-up is not specified.

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NCT04927416

The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer

Recruiting
PHASE2Ages 18–98InterventionalDiagnostic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
~54 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:68-Gallium-DOTATATE-PET/CT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of patients with metastatic RAI-non-avid or RAI-non-responsive thyroid cancer whose tumors are characterized by a high SSTR2 expression by imaging with 68Ga-DOTATATE PET/CT
Measured over During baseline assessment

Conditions

Metastic Thyroid Cancer

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Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Joanna Klubo-Gwiezdzinska, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who to contact

Padmasree Veeraraghavan, R.N.
[email protected]
(301) 451-7710
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)
Patients with RAI-non-responsive disease, who have the evidence of disease progression defined by RECIST 1.1 criteria after therapy with RAI.
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

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.

What this trial measures

  • Prevalence of patients with metastatic RAI-non-avid or RAI-non-responsive thyroid cancer whose tumors are characterized by a high SSTR2 expression by imaging with 68Ga-DOTATATE PET/CTDuring baseline assessment

    Prevalence of thyroid cancer patients characterized by a high SSTR2 expression in at least one metastatic lesion per patient documented by SUVmax of 68Ga-DOTATATE-PET/CT of above 15 among patients with metastatic HTC, DTC and MTC.