Randomized Trial of Gallium-68 Pentixafor PETCT Added to Adrenal Venous Sampling to Improve Surgery Outcomes in Primary Aldosteronism

What this Trial Is About

Researchers are evaluating the clinical usefulness of adding gallium-68 pentixafor PETCT imaging to the standard adrenal venous sampling AVS procedure for managing primary aldosteronism PA. This condition causes secondary hypertension, and accurate identification of whether PA affects one adrenal gland or both is crucial for deciding between surgery or medication. This randomized controlled trial aims to see if combining 68Ga-pentixafor PETCT with AVS improves surgical outcomes for patients with unilateral PA compared to AVS alone. Participants are randomly assigned to one of two groups one receiving the standard AVS procedure alone, and the other receiving AVS plus 68Ga-pentixafor PETCT imaging. Additionally, those in the intervention group undergo 11C-metomidate PETCT scans for research purposes only, which do not influence treatment decisions. The study focuses on improving the precision of subtype classification to better select patients for adrenalectomy. During the study, participants undergo imaging and sampling procedures before treatment. Researchers will collect data on biochemical remission rates six months after adrenalectomy in the surgery group, as well as clinical remission rates after surgery or medical therapy. They will also assess the agreement between imaging and AVS results, correlate imaging findings with tissue analysis, and monitor changes in blood pressure, medication use, and lab values. The overall goal is to enhance treatment decisions and outcomes for people with primary aldosteronism.

PETAL Trial: Impact of Gallium-68 Pentixafor PET-CT on Surgical Outcomes in Primary Aldosteronism