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

February 3, 2026 updated by: Qifu Li

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • The First Affilated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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. Exclusion criteria

Exclusion Criteria:

  • 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];
  • Suspicion of pheochromocytoma or adrenal carcinoma;
  • Patients with actively malignant tumor;
  • Patients who have adrenalectomy history;
  • Long-term use of glucocorticoids;
  • Pregnant or lactating women; with alcohol or drug abuse and mental disorders;
  • Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 3 months; Severe anemia (Hb<60g/L); Serious liver dysfunction or chronic kidney disease aspartate aminotransferase (AST) or alanine transaminase (ALT) >3 times the upper limit of normal, or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2); Systemic Inflammatory Response Syndrome (SIRS); Uncontrolled diabetes (FBG≥13.3 mmol/L); Obesity (BMI≥35 kg/m²) or Underweight (BMI≤18 kg/m²); Untreated aneurysm; Other comorbidity potentially interfering with treatment;
  • Suspected PBMAH or PPNAD;
  • Poor compliance or any other reason deemed unsuitable for inclusion by the investigators;
  • Patients with adrenal insufficiency requiring hormone replacement therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-Pentixafor PET/CT group
Patients in the 68Ga-Pentixafor PET/CTgroup will first undergo 68Ga-Pentixafor PET/CT, followed by adrenal venous sampling (AVS). The subsequent treatment will be guided based on the diagnostic results.
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
Experimental: AVS group
Patients in the adrenal venous sampling (AVS) will first undergo adrenal venous sampling (AVS) , followed by 68Ga-Pentixafor PET/CT. The subsequent treatment will be guided based on the diagnostic results.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of complete biochemical remission
Time Frame: At 6 months of follow-up
Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.
At 6 months of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of complete clinical remission
Time Frame: At 6 months of follow-up
Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.
At 6 months of follow-up
In surgical population, the proportion of complete biochemical remission
Time Frame: At 6 months of follow-up
Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.
At 6 months of follow-up
In surgical population, the proportion of complete clinical remission
Time Frame: At 6 months of follow-up
Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.The proportion of complete biochemical remission according to PASO consensus criteria.
At 6 months of follow-up
In surgical population, the accuracy in identifying unilateral primary aldosteronism.
Time Frame: At 6 months of follow-up
Blood was drawn to measure aldosterone, renin and potassium.According to PASO criteria, outcomes of adrenalectomy for unilateral primary aldosteronism were classified into complete, partial, and absent success, for both clinical and biochemical outcomes.the accuracy in identifying unilateral primary according to PASO consensus criteria.
At 6 months of follow-up
In the surgical treatment group, the remission rate of cortisol autonomous secretion
Time Frame: at the 6-month follow-up assessment
Blood was drawn to measure cortisol.The remission of cortisol autonomous secretion is defined as cortisol after 1mg dexamethasone suppression test <1.8 μg/dL.
at the 6-month follow-up assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qifu Li

Collaborators

Changzhi Medical College
The Affiliated Hospital Of Southwest Medical University
First Affiliated Hospital of Kunming Medical University

Investigators

  • Study Chair: Qifu Li, the Chongqing Primary Aldosteronism Study (CONPASS) Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

February 13, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDICT (CardioDx)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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