Overview
- 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:
- Evaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
- 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:
- Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with sporadic primary hyperparathyroidism
- Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with multi-gland disease (suspected or diagnosed with heritable forms of PHPT)
- Endpoints
Primary Endpoints:
- Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT).
- 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 Endpoint:
- Positive predictive value of 18F-FCH PET/MRI and PET/CT vs. 4D-CT
Eligibility
- INCLUSION CRITERIA:
To be eligible to participate in this study, an individual must meet all the following criteria:
- Aged 18-100 years old
- Willing to have parathyroidectomy at NIH Clinical Center
- Meets one of the following:
- Diagnosed with sporadic PHPT and is a potential candidate for parathyroidectomy.
- 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 hyperparathyroidism) or germline predisposition PHPT syndrome are included in this cohort
- Suspected to have, or diagnosed with, parathyroid cancer and is a potential candidate for parathyroidectomy.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Known allergic reactions to components of the 18F-Fluorocholine radiopharmaceutical.
- For persons able to become pregnant: unwilling to use highly effective contraception for at least two weeks prior to date of the first imaging scan through the date of the parathyroidectomy surgery
- Use of any investigational product or device, excluding F-DOPA scans, within 30 days prior to the 18F-FCH scan.
- Unable or unwilling to provide informed consent.
- Any other condition that would prevent the safe completion of study participation in the clinical opinion of the investigators.
