NCT06833437 68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Diagnosing Unilateral Subtype of Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion (PREDICT)
| NCT ID | NCT06833437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qifu Li |
| Condition | Primary Aldosteronism |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 178 participants in total. It began in 2024-08-01 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Qifu Li
STUDY CHAIR
the Chongqing Primary Aldosteronism Study (CONPASS) Group
Frequently Asked Questions
Who can join the NCT06833437 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Primary Aldosteronism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06833437 currently recruiting?
Yes, NCT06833437 is actively recruiting participants. Contact the research team at liqifu@yeah.net for enrollment information.
Where is the NCT06833437 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT06833437 clinical trial?
NCT06833437 is sponsored by Qifu Li. The principal investigator is Qifu Li at the Chongqing Primary Aldosteronism Study (CONPASS) Group. The trial plans to enroll 178 participants.