RecruitingPhase 2Phase 3NCT07444723

Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors

A Phase II Study of Accuracy of 18F-Fluorocholine PET/MRI and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors


Sponsor

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

Enrollment

193 participants

Start Date

Apr 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Background: People have 4 parathyroid glands near the thyroid gland in the neck. Surgery is needed to remove a parathyroid gland that is too large or has a tumor. These glands can be in different places, so doctors use an imaging scan with contrast dye to help find them before surgery. Researchers want to know if a different type of scan and a new tracer can make it easier to find the tumors in the parathyroid glands. Objective: To see if PET/MRI and NeuroEXPLORER PET-CT scans with a 18F-FCH tracer are better than existing methods for finding the parathyroid glands. Eligibility: People aged 18 years or older who are scheduled for surgery to remove a parathyroid gland. Design: Participants will have up to 4 clinic or hospital visits. They will be screened. They will have a physical exam and give blood samples. Participants will have a 4-dimensional computed tomography (4D-CT) scan. This is the current way doctors look for parathyroid glands. They will be injected with an iodine-based dye for the 4D-CT scan. They will lie on a padded table that slides into a donut-shaped machine. Participants will have a positron emission tomography (PET)-magnetic resonance imaging (MRI) and NeuroEXPLORER PET-CT scan. For these scans, they will be injected with a radioactive tracer (18F-FCH). They will wait about 30 to 60 minutes for their body to absorb the tracer. They will lie on a padded table that slides into a tube. Their vital signs will be monitored during the scan. Participants will have surgery to remove the target gland. They may need to stay in the hospital for up to 3 nights. Participants will have a follow-up visit 6 months after the surgery. This may be done remotely....


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 18F-FCH and a medical device called NeuroEXPLORER for people with heritable hyperparathyroidism, hyperparathyroid-jaw tumor syndrome, and other related conditions. The study is currently recruiting participants at 1 location.

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

DRUG18F-FCH

Radiotracer for use in PET/MRI and PET/CT

DEVICENeuroEXPLORER

PET/CT machine


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT07444723


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