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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • 68Ga-Pentixafor PET/CT

    Diagnostic test

    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

  • AVS

    Diagnostic test

    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

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: 68Ga-Pentixafor PET/CT groupExperimental treatment 1 intervention
Group B: AVS groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of complete biochemical remission

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.

Time frame
At 6 months of follow-up

Secondary outcomes

1

The proportion of complete clinical remission

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.

Time frame
At 6 months of follow-up
2

In surgical population, the proportion of complete biochemical remission

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.

Time frame
At 6 months of follow-up
3

In surgical population, the proportion of complete clinical remission

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.

Time frame
At 6 months of follow-up
4

In surgical population, the accuracy in identifying unilateral primary aldosteronism.

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.

Time frame
At 6 months of follow-up

Other outcomes

Sponsors and contacts

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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