Study of Al18F-NOTA-Pentixafor PETCT Imaging for Diagnosing and Guiding Surgery in Primary Aldosteronism

What this Trial Is About

Primary aldosteronism PA is a leading cause of secondary hypertension and affects millions worldwide. This study evaluates a new imaging method, Al18F-NOTA-Pentixafor PETCT, which targets a receptor called CXCR4 found on aldosterone-producing adenomas. Researchers aim to assess how this imaging works, its safety, and how well it helps guide surgery decisions for patients with PA in a prospective, single-center trial. Participants will receive an intravenous injection of the Al18F-NOTA-Pentixafor tracer. After injection, PET and CT scans will be performed within 45-90 minutes to visualize CXCR4-positive lesions. The study will monitor tracer distribution and radiation dose and track diagnostic accuracy and surgical outcomes guided by this imaging over 1 to 1.5 years, including a 6-month follow-up after surgery. Throughout the study, participants will undergo safety assessments from the time of tracer injection up to 24 hours afterward. Researchers will also evaluate diagnostic accuracy based on clinical or pathological diagnoses at 6 months post-imaging and surgical results. Additional measurements include organ uptake of the tracer and radiation dose, monitored up to 6 months after study completion. Participation involves imaging procedures, follow-up visits, and adherence to contraception requirements when applicable.

Application of Al18F-NOTA-Pentixafor PET/CT for Primary Aldosteronism