Comparing two methods for assessing primary aldosteronism outcomes
68Ga-Pentixafor PET/CT Versus Adrenal Vein Sampling to Determine Treatment in Primary Aldosteronism: A Multicenter Randomized Clinical Trial
This study is testing whether a new imaging method or a traditional sampling method is better for helping people with primary aldosteronism and adrenal nodules to manage their condition over the long term.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06238232 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of 68Ga-Pentixafor PET/CT versus adrenal vein sampling (AVS) in determining long-term outcomes for patients with primary aldosteronism who have adrenal nodules of 1 cm or larger. A total of 320 patients will be randomly assigned to either the PET/CT intervention group or the AVS control group. The study will evaluate which method provides better long-term results for managing primary aldosteronism. Participants must meet specific criteria related to their condition and willingness to undergo surgery.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18-70 with primary aldosteronism and adrenal nodules of at least 1 cm who are willing to undergo surgery.
Not a fit: Patients with conditions such as autonomous cortisol secretion, familial hyperaldosteronism, or those with a history of adrenalectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for patients with primary aldosteronism.
How similar studies have performed: While there have been studies on adrenal vein sampling, the use of 68Ga-Pentixafor PET/CT in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chongqing, Chongqing Municipality
- The First Affilated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Qifu Li, PhD
- Email: liqifu@yeah.net
- Phone: +86 023-89011552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.