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Clinical Trials in China / NCT06833437
Recruiting Not applicable

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

NCT06833437 · tracked via the Priya Life Science China tracker
Sponsor
Qifu Li
Phase
Not applicable
Started
2024-08-01
Last updated
2026-02-05

Condition(s) studied

Primary AldosteronismAutonomous Cortisol Secretion

Investigational drug(s) / intervention(s)

68Ga-Pentixafor PET/CTAVS

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

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affilated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06833437 on ClinicalTrials.gov ↗ ← All trials in China