Actively Recruiting

Phase 2
Age: 18Years - 98Years
All Genders
NCT04927416

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

Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12

54

Participants Needed

1

Research Sites

474 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 98Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged over 18 years
  • Diagnosis of Hurthle cell, differentiated, or medullary thyroid cancer
  • Locally advanced or metastatic disease
  • For differentiated thyroid cancer: tumors that are radioactive iodine non-avid or show disease progression after radioactive iodine therapy
  • For medullary thyroid cancer: locally advanced or metastatic disease, or suspicion of such with calcitonin level greater than 500 pg/mL
Not Eligible

You will not qualify if you...

  • Pregnancy or lactation by self-report
  • Serious medical conditions limiting testing or therapy, such as renal failure, congestive heart failure, or active non-thyroid cancer
  • Inability to provide informed consent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

P

Padmasree Veeraraghavan, R.N.

CONTACT

J

Joanna Klubo-Gwiezdzinska, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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