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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorQifu Li

About this 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.

Eligibility criteria

Qualifiers

Getting the written informed consent;

PA conccurent with autonomous cortisol secretion;

Patients with hypertension aged 18-70 years;

CT or MRI scan of the adrenal glands with adenoma.

Disqualifiers

Unable to complete 68Ga-Pentixafor PET/CT or AVS;

Refusal of surgery or contraindications for surgery;

PA patients who meet the by-passing AVS criteria [i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (≥1cm), plasma aldosterone >300pg/ml]

Suspicion of familial hyperaldosteronism or Liddle syndrome. [i.e., age <20 years, hypertension and hypokalemia, or with family history];

Trial design

Treatments tested in this trial

  • 68Ga-Pentixafor PET/CT
  • AVS

Treatment groups

178 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Qifu Li

Lead sponsor

Chongqing Medical University

Sponsor institution

The Affiliated Hospital Of Southwest Medical University

Collaborator

Changzhi Medical College

Collaborator

First Affiliated Hospital of Kunming Medical University

Collaborator