Actively Recruiting
Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Led by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Updated on 2026-05-12
193
Participants Needed
1
Research Sites
511 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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....
CONDITIONS
Official Title
Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 100 years old
- Willing to have parathyroidectomy at NIH Clinical Center
- Diagnosed with sporadic primary hyperparathyroidism and a potential candidate for parathyroidectomy
- Diagnosed with any form of heritable primary hyperparathyroidism (new or recurrent) and a potential candidate for parathyroidectomy
- Clinically suspected of multi-gland disease or germline predisposition primary hyperparathyroidism syndrome
- Suspected or diagnosed with parathyroid cancer and a potential candidate for parathyroidectomy
You will not qualify if you...
- Pregnancy or lactation
- Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical
- For those able to become pregnant: unwilling to use highly effective contraception from two weeks before the first imaging scan until the date of parathyroidectomy
- Use of any investigational product or device, except F-DOPA scans, within 30 days before the 18F-FCH scan
- Unable or unwilling to provide informed consent
- Any condition that would prevent safe completion of study participation as judged by investigators
AI-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
Research Team
L
Lynn M Bliss
CONTACT
S
Smita Jha, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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