NCT07444723

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 193 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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....

Detailed 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 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

Conditions

• Primary Hyperparathyroidism
• Parathyroid Cancer
• Multiple Endocrine Neoplasias
• Heritable Hyperparathyroidism
• Hyperparathyroid-jaw Tumor Syndrome

Interventions

Type	Name	Description
DRUG	18F-FCH	Radiotracer for use in PET/MRI and PET/CT
DEVICE	NeuroEXPLORER	PET/CT machine

Timeline

• Start date: 2026-04-22
• Primary completion: 2035-02-05
• Completion: 2036-02-05
• First posted: 2026-03-03
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study