68Ga-Pentixafor PET/CT to find the dominant source of hormone excess in PA with mild autonomous cortisol secretion
Official title: Diagnostic Value of 68Ga-Pentixafor PET/CT in Adrenal Tumors With Aldosterone and Cortisol Cosecretion
Run by Peking University First Hospital · NCT07605156 · Data updated 2026-11-12
A non-randomized study tests whether 68Ga-Pentixafor PET/CT can correctly identify which side of the adrenal glands is driving excess aldosterone and cortisol in adults with PA and MACS.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | May 31, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT07605156 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with PA+MACS who are planned for unilateral adrenalectomy or ablation and can undergo 68Ga-Pentixafor PET/CT.
✕Probably not a fit
Patients with contraindications to PET/CT, those without suitable anatomy or resolution, or whose disease does not lateralize with imaging may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will compare 68Ga-Pentixafor-CXCR4 PET/CT results to the surgical reference standard (PASO outcomes) for lateralizing aldosterone and cortisol excess. It will also examine how PET/CT results align with adrenal venous sampling and metanephrine-corrected AVS, and identify factors that predict discordance. Eligible adults (18–80) scheduled for unilateral adrenalectomy or ablation and meeting PA+MACS criteria will undergo PET/CT prior to surgery, with follow-up of at least 12 months. The study aims to quantify diagnostic performance using AUC and characterize potential clinical predictors. This is an imaging-focused observational study without an interventional treatment component.
Why it matters
Potential benefit: If successful, this imaging approach could help guide surgical decisions by accurately lateralizing hormone excess.
How similar studies have gone: Prior studies suggest PET/CT for receptor-targeted imaging can aid lateralization, but this specific CXCR4-targeted approach in PA+MACS is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-80 years. Confirmed diagnosis of PA+MACS according to guideline-directed algorithms: elevated aldosterone-to-renin ratio (ARR) and at least one positive confirmatory test for primary aldosteronism, together with serum cortisol \>1.8 µg/dL (\>50 nmol/L) after a 1 mg overnight dexamethasone suppression test (1 mg-ONDST). Scheduled to undergo \[⁶⁸Ga\]Pentixafor-CXCR4 PET/CT imaging. Meeting surgical indications, scheduled for adrenalectomy or adrenal ablation, having provided written informed consent, and agreeing to a follow-up of at least 12 months. Exclusion Criteria: * Previous adrenal surgery or confirmed adrenal malignancy. Pregnancy or lactation. Severe renal impairment (eGFR \<30 mL·min-¹·1.73 m-²) or contraindication to contrast agents/radiopharmaceuticals. Inability to discontinue medications that interfere with diagnostic testing according to protocol, or presence of severe infection/unstable comorbidities that preclude relevant examinations. Definite overt Cushing's syndrome (CS). Critical missing data, inability to complete the required examinations, or anticipated inability to attend follow-up.
Where it's running
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Peking University First Hospital, Beijing
Beijing, China Recruiting
Study contacts
- Study coordinator: Baojiang Wu Wu
- Email: 2300736651@qq.com
- Phone: 01013231338962
Similar studies
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This study is testing if a special type of PET/CT scan can help diagnose a specific adrenal gland disorder in patients who have adrenal nodules and are considering surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.