Phase 2 Study Using 68GaGa-PentixaFor PET Scans to Identify Functional Adrenal Tumors in Adults with Hyperaldosteronism or Hypercortisolism

What this Trial Is About

Researchers are studying adrenal tumors, which can either release hormones functional or not nonfunctional. The study aims to evaluate a new radioactive tracer called 68GaGa-PentixaFor to improve the detection of functional adrenal tumors using PET scans. This tracer targets a receptor expressed in certain adrenal tumors related to conditions like hyperaldosteronism and hypercortisolism, which affect hormone levels. Identifying the type of tumor helps doctors manage treatment options better. Participants will receive an injection of the 68GaGa-PentixaFor tracer about one hour before having a PETCT or PETMR scan. The scan takes between 45 and 90 minutes while participants lie still. The study includes three groups based on the type of adrenal condition they have. After the scan, a safety check will occur three days later, which can be done by phone, email, or in person. Participants remain in the study for up to one year for additional sample collection and analysis related to their adrenal condition. During the study, participants will have their heart rate, blood pressure, and breathing monitored before, during, and after the scan. Researchers will compare the imaging results with clinical diagnoses to see how well the tracer identifies functional adrenal tumors. They will also evaluate the tracers safety and study its uptake in tissue samples when available. The total involvement includes the scan day, follow-up safety visit, and up to one year of additional monitoring and sample collection.

Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism