Comparing 68Ga-Pentixafor PETCT and Adrenal Vein Sampling for Diagnosing Unilateral Primary Aldosteronism with Autonomous Cortisol Secretion in Adults

What this Trial Is About

Researchers are evaluating the accuracy of two diagnostic methods, 68Ga-Pentixafor PETCT and adrenal venous sampling AVS, in identifying the subtype of primary aldosteronism PA concurrent with autonomous cortisol secretion ACS in patients with adrenal nodules. This prospective, multicenter, randomized crossover trial aims to compare the diagnostic performance of these methods based on biochemical and clinical remission outcomes, focusing on whether 68Ga-Pentixafor PETCT is not less accurate than AVS. The main goal is to guide treatment decisions effectively based on these diagnostic results. Participants are randomly assigned to one of two groups one group undergoes 68Ga-Pentixafor PETCT first followed by AVS, and the other group undergoes AVS first followed by 68Ga-Pentixafor PETCT. Treatment strategies are then guided by the diagnostic findings. Both interventions are diagnostic tests used to determine unilateral primary aldosteronism, with specific criteria for diagnosis based on imaging and sampling results. This crossover design allows each patient to receive both diagnostic methods in different orders. During the study, participants will be monitored with a primary focus on the proportion of complete biochemical remission at 6 months postoperatively. Additional assessments include clinical remission rates and diagnostic accuracy in the surgical population. The study includes follow-up visits at 6 months after treatment to evaluate outcomes. Safety and treatment effectiveness are monitored throughout the trial, which is expected to last until the end of 2029.

68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT)