RecruitingPhase 2NCT04927416

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


Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrollment

54 participants

Start Date

Oct 25, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 98 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a special type of PET scan using a tracer called 68Ga-DOTATATE can better detect and map metastatic thyroid cancer compared to standard imaging. It focuses on three types of thyroid cancer: differentiated, Hürthle cell, and medullary thyroid cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with thyroid cancer (differentiated, Hürthle cell, or medullary type) that has spread - You are a patient at the NIH Clinical Center **You may NOT be eligible if...** - You have a condition that makes you unable to tolerate the scan - You do not have confirmed metastatic thyroid cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG68-Gallium-DOTATATE-PET/CT

68Ga-DOTATATE is administered one-time via intravenous injection of 5 mCi in a volume of 3-5 ml containing up to 50 mcg \[68Ga\] DOTATATE.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT04927416