Clinical trial NCT06833437: 68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Aldosteronism
Autonomous Cortisol Secretion
Keywords: Primary aldosteronism
Autonomous cortisol secretion
Adrenal venous sampling
68Ga-Pentixafor PET/CT
outcome
multicenter randomized crossover trial
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital Of Southwest Medical University
name: Changzhi Medical College
name: First Affiliated Hospital of Kunming Medical University
First posted: 2025-02-18
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of complete biochemical remission
timeFrame: At 6 months of follow-up
Secondary outcomes:
measure: The proportion of complete clinical remission
timeFrame: At 6 months of follow-up
measure: In surgical population, the proportion of complete biochemical remission
timeFrame: At 6 months of follow-up
measure: In surgical population, the proportion of complete clinical remission
timeFrame: At 6 months of follow-up
measure: In surgical population, the accuracy in identifying unilateral primary aldosteronism.
timeFrame: At 6 months of follow-up
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affilated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: the Chongqing Primary Aldosteronism Study (CONPASS) Group
name: Qifu Li
role: STUDY_CHAIR
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