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68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT): a Randomized Cross-over Trial
To validate the accuracy of 68Ga-Pentixafor PET/CT and adrenal venous sampling (AVS) in subtype diagnosis of PA/ACS patients with adrenal nodules, based on biochemical and clinical remission outcomes, and to determine whether the diagnostic accuracy of 68Ga-Pentixafor PET/CT is non-inferior to AVS.
This is a prospective, multicenter, randomized crossover trial. Patients with a confirmed diagnosis of primary aldosteronism (PA) or autonomous cortisol secretion (ACS) with adrenal nodules were prospectively enrolled. They were randomized to undergo 68Ga-Pentixafor PET/CT and adrenal venous sampling (AVS) in a crossover design for subtype diagnosis. The treatment strategy was determined based on the diagnostic results, with the primary endpoint being the biochemical complete remission rate at 6 months postoperatively. The study aims to compare the value of these two methods in the subtype diagnosis of PA.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
The First Affilated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Start Date
August 1, 2024
Primary Completion Date
December 31, 2028
Completion Date
December 31, 2029
Last Updated
February 5, 2026
178
ESTIMATED participants
68Ga-Pentixafor PET/CT
DIAGNOSTIC_TEST
AVS
DIAGNOSTIC_TEST
Lead Sponsor
Qifu Li
Collaborators
NCT05405101
NCT07378176
NCT06941116
Data Source & Attribution
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