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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 276 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fields
  2. Minor Interventions: 68-Gallium-DOTATATE-PET/CT (Drug) to 68-Gallium-DOTATATE-PET/CT (Drug) Eligibility criteria expanded, about 9 words · Study description expanded, about 7 words Show 2 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 7 words
  3. Minor 39 versions Re-verified since Sep 12, 2025, no change to tracked fieldsv236-v274
  4. Minor Study Status, Study Description, Eligibilityv235
  5. Minor 8 versions Re-verified since May 14, 2025, no change to tracked fieldsv227-v234
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: About 5% to 10% of differentiated thyroid cancers become resistant to standard treatment with radioactive iodine. In these cases, treatment options are limited and generally not effective. Researchers want to see if they can better detect thyroid tumors by using a compound called 68Gallium-DOTATATE. This compound may bind to a tumor and make it visible during a positron emission tomography/computed tomography (PET/CT) scan. This information might help guide future research and treatment. Objective: To identify the people with thyroid cancer whose tumors have a high uptake of 68Gallium-DOTATATE as analyzed by imaging with PET/CT. Eligibility: People ages 18 years and older with thyroid cancer that has spread outside of the thyroid. Design: Participants will have a medical exam. They will give blood and urine samples. Some samples will be used for research. Participants will have imaging scans that follow standard of care. These scans may include: CT scan of the neck, chest, abdomen, and pelvis Bone scan Magnetic resonance imaging of the brain, spine, or liver 18-FDG-PET/CT as needed Participants will have a PET/CT scan. They will get an intravenous (IV) line. They will get an IV injection of 68Gallium-DOTATATE. It contains radioactive tracers. The PET/CT scanner is shaped like a large donut. It contains crystals. The crystals pick up small radiation signals that are given off by the tracers. The CT part of the scan uses low-dose x-rays. The pictures made by the scanner show where the tracers are in the body. The session will last 90 minutes. Participation will last for about 3 months.
Trial Details
NCT Number NCT04927416
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Metastic Thyroid Cancer
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov