A Phase II Study of Accuracy of 18F-Fluorocholine PET/MRI and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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....
Description
Study Description: This study investigates the efficacy of 18F-FCH PET/ MRI and PET/CT for localization of parathyroid tumors in primary hyperparathyroidism (sporadic or heritable forms and parathyroid cancer). Objectives: Primary Objectives: 1. Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT) 2. Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with multi-gland disease (suspected or diagnosed with heritable forms of PHPT) Secondary Objective: 1. Compare positive predictive val…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all the following criteria: 1. Aged 18-100 years old 2. Willing to have parathyroidectomy at NIH Clinical Center 3. Meets one of the following: 1. Diagnosed with sporadic PHPT and is a potential candidate for parathyroidectomy. 2. Diagnosed with any forms of heritable primary hyperparathyroidism (index presentation or recurrent disease) and is a potential candidate for parathyroidectomy. Participants clinically suspected of multi-gland disease (individuals with secondary/tertiary hyperparathyroi…
Interventions
- Drug18F-FCH
Radiotracer for use in PET/MRI and PET/CT
- DeviceNeuroEXPLORER
PET/CT machine
Location
- National Institutes of Health Clinical CenterBethesda, Maryland