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

• Status: Recruiting
• Trial end date: 2030-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Criteria

• INCLUSION CRITERIA:

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 68Gallium-DOTATATE PET/CT imaging informed consent form

In order to be eligible to participate in this study, an individual with DTC (including HTC) must meet all of the following criteria:

1. Male or female, aged >=18 years.

2. Patients with established thyroid cancer diagnosis presenting with either:

1. Locally advanced or distant metastases, which are RAI-non-avid based on the or diagnostic or post-treatment whole body scan (WBS) OR

2. Patients with RAI-non-responsive disease, who have the evidence of disease progression defined by RECIST 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:

1. Male or female, aged >=18 years.

2. 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:

1. Pregnancy or lactation

2. Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma;

3. Patients unable to give informed consent.