Phase II and III Study of 18F-Fluorocholine PETMRI and NeuroEXPLORER PETCT Scans to Locate Parathyroid Tumors in Adults Undergoing Parathyroidectomy

What this Trial Is About

Researchers are studying ways to improve the detection of parathyroid tumors in people with primary hyperparathyroidism, including sporadic and heritable forms, as well as parathyroid cancer. This trial evaluates whether PETMRI and NeuroEXPLORER PETCT scans using an 18F-Fluorocholine 18F-FCH tracer provide better localization of parathyroid glands compared to the current standard, 4-dimensional computed tomography 4D-CT. The study is conducted by the National Institute of Diabetes and Digestive and Kidney Diseases NIDDK and aims to measure the positive predictive value of these imaging methods. Participants will receive an injection of the 18F-FCH tracer before undergoing PETMRI and NeuroEXPLORER PETCT scans, after which their vital signs will be monitored during the procedures. They will also have a 4D-CT scan with an iodine-based contrast dye, which is the current standard for locating parathyroid glands. Following the imaging, participants will undergo surgery to remove the affected parathyroid gland, and may stay in the hospital for up to three nights. The study includes up to four visits, including screening and follow-up. During the study, participants will have physical exams, blood samples taken, and the imaging tests described above. After surgery, a follow-up visit will occur about six months later, which may be conducted remotely. The main outcomes measured are the accuracy and predictive value of the new PETMRI and PETCT scans compared to the standard 4D-CT. Researchers will also monitor participant safety and recovery throughout the study period, which may last up to several years until final data collection in 2036.

Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors