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

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - 70 years
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 178 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

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Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Double masked

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

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

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

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