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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)

NCT06833437 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2026-02-05

No results posted yet for this study

Summary

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.

Conditions

  • Primary Aldosteronism
  • Autonomous Cortisol Secretion

Interventions

DIAGNOSTIC_TEST

68Ga-Pentixafor PET/CT

Patients in the 68Ga-Pentixafor PET/CT group will first undergo 68Ga-Pentixafor PET/CT, followed by adrenal venous sampling (AVS). The subsequent treatment will be guided based on the diagnostic results. The diagnosis of unilateral PA was made if LISUVmax ≥1.50 or or unilateral functional adrenal tumor based on 68Ga-Pentixafor PET/CT

DIAGNOSTIC_TEST

AVS

Patients in the adrenal venous sampling (AVS) group will first undergo adrenal venous sampling (AVS), followed by 68Ga-Pentixafor PET/CT. The subsequent treatment will be guided based on the diagnostic results. The diagnosis of unilateral PA was made LI ≥ 4 or LI 2-4 with contralateral suppression or typical nodule on the dominant side by CT

Sponsors & Collaborators

  • The Affiliated Hospital Of Southwest Medical University

    collaborator OTHER

  • Changzhi Medical College

    collaborator OTHER

  • First Affiliated Hospital of Kunming Medical University

    collaborator OTHER

  • Qifu Li

    lead OTHER

Principal Investigators

  • Qifu Li · the Chongqing Primary Aldosteronism Study (CONPASS) Group

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06833437 on ClinicalTrials.gov