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....
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 value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with sporadic primary hyperparathyroidism 2. 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: 1. Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT). 2. 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: a. Positive predictive value of 18F-FCH PET/MRI and PET/CT vs. 4D-CT
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
193
Radiotracer for use in PET/MRI and PET/CT
PET/CT machine
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
RECRUITINGEvaluate positive predictive value of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
Biochemical cure in conjunction with histological findings is the standard endpoint to confirm cure. Positive Predictive Value (PPV) is defined as the ability to distinguish between a true positive and a false positive
Time frame: Positive predictive Value (PPV) 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 sporadic primary hyperparathyroidism (PHPT)
Biochemical cure in conjunction with histological findings is the standard endpoint to confirm cure. Positive Predictive Value (PPV) is defined as the ability to distinguish between a true positive and a false positive when considering only positive diagnostic assessments. Positive Predictive Value would help in assessing frequency of false positives: Positive predictive value = true positive/ \[true positives + false positives\]
Time frame: Positive predictive Value (PPV) of 18F-FCH PET/MRI and PET/CT in participants with sporadic primary hyperparathyroidism (PHPT)
Compare positive predictive value of 18F-FCH PET/MRI and PET/CT to 4D-CT in participants with sporadic primary hyperparathyroidism (PHPT)
Will allow comparison of 18FFCH PET/MRI and PET/CT to conventional imaging.
Time frame: Positive predictive value of 18F-FCH PET/MRI and PET/CT vs. 4D-CT
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