NCT06238232 Outcome of 68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling in Primary Aldosteronism
| NCT ID | NCT06238232 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Qifu Li |
| Condition | Primary Aldosteronism |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2024-01-09 |
| Primary Completion | 2026-12-31 |
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 320 participants in total. It began in 2024-01-09 with a primary completion date of 2026-12-31.
⚠ 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 compare the 68Ga-Pentixafor PET/CT and adrenal vein sampling on the long-term outcomes of primary aldosteronism (PA) patients with adrenal nodule (≥1cm)
Eligibility Criteria
Inclusion Criteria: (1)Getting the written informed consent (2)ARR ≥20 (pg/ml)/ (μIU/ml) or ARR ≥ 30(ng/dL)/(ng/ml/hr) plus at least one positive PA confirmatory test (CCT, SSIT). (3)Patients who are willing to undergo surgery. (4)Patients with hypertension aged 18-70 years. (5)CT or MRI scan of the adrenal glands with nodule (≥1cm). Exclusion criteria 1. Combined with autonomous cortisol secretion, cortisol after 1mg dexamethasone suppression test (DST) ≥50 nmol/l. 2. PA patients who meet the by-passing AVS criteria \[i.e., younger than 35 years old, spontaneous hypokalemia, adrenal CT indicated unilateral low-density adenoma (≥1cm), plasma aldosterone \>300pg/ml\] 3. Suspicion of familial hyperaldosteronism or Liddle syndrome. \[i.e., age \<20 years, hypertension and hypokalemia, or with family history\] 4. Suspicion of pheochromocytoma or adrenal carcinoma. 5. Patients with actively malignant tumor. 6. Patients who have adrenalectomy history or with adrenocortical insufficiency. 7. Long-term use of glucocorticoids. 8. Pregnant or lactating women; with alcohol or drug abuse and mental disorders. 9. 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
Contact & Investigator
Qifu Li, PhD
STUDY CHAIR
the Chongqing Primary Aldosteronism Study (CONPASS) Group
Frequently Asked Questions
Who can join the NCT06238232 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 NCT06238232 currently recruiting?
Yes, NCT06238232 is actively recruiting participants. Contact the research team at liqifu@yeah.net for enrollment information.
Where is the NCT06238232 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT06238232 clinical trial?
NCT06238232 is sponsored by Qifu Li. The principal investigator is Qifu Li, PhD at the Chongqing Primary Aldosteronism Study (CONPASS) Group. The trial plans to enroll 320 participants.