Using Gallium-68 Pentixafor PET-CT to improve surgery outcomes in primary aldosteronism
Official title: A Randomized Controlled Trial to Evaluate the Effect of Gallium-68 Pentixafor PET-CT on Surgical Outcomes in Patients With Primary Aldosteronism (The PETAL Trial)
Run by Seoul National University Hospital · NCT07027254 · Data updated 2026-11-12
This trial will test whether adding gallium-68 pentixafor PET/CT to standard adrenal venous sampling helps people with primary aldosteronism have better results from adrenal surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 2 sites (Seoul, Gangnam-gu and 1 other locations) |
| Status | Recruiting |
| Started | June 25, 2025 |
| Main results expected | June 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | June 18, 2025 |
| Trial ID | NCT07027254 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19 or older diagnosed with primary aldosteronism who have undergone adrenal CT, are candidates for surgery, and can consent to AVS and imaging are ideal candidates.
✕Probably not a fit
People who refuse surgery, cannot undergo AVS or PET/CT, are pregnant or breastfeeding, or have bilateral disease unlikely to benefit from unilateral adrenalectomy may not gain 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 randomized controlled trial enrolls adults with primary aldosteronism and randomizes them 1:1 to receive standard adrenal venous sampling (AVS) alone or AVS plus 68Ga‑pentixafor PET/CT before treatment decisions. In the intervention arm, 11C‑metomidate PET/CT is also performed for research purposes only and does not influence clinical management. The study aims to determine if adding pentixafor PET/CT improves lateralization accuracy and subsequent surgical outcomes such as biochemical and blood pressure remission. The trial is being conducted at two tertiary hospitals in Seoul with standard perioperative care and follow-up to capture clinical outcomes.
Why it matters
Potential benefit: If successful, adding 68Ga‑pentixafor PET/CT could improve selection of patients for adrenalectomy and lead to better blood pressure control and higher rates of biochemical cure.
How similar studies have gone: Previous imaging studies report moderate-to-high concordance of pentixafor PET/CT with AVS (about 66–90%), but prospective evidence that PET/CT improves surgical outcomes is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥19 years * Diagnosed with PA per 2016 Endocrine Society guidelines * Underwent adrenal CT * Signed informed consent Exclusion Criteria: * Women who are pregnant, breastfeeding, or may become pregnant * Individuals who refuse to undergo surgery * Individuals for whom 68Ga-Pentixafor PET/CT, 11C-Metomidate PET/CT, or adrenal venous sampling (AVS) is not feasible or is refused due to underlying conditions * Individuals who refuse or experience adverse effects from dexamethasone premedication required for 11C-Metomidate PET/CT * Individuals with a history of abdominal open surgery or retroperitoneal surgery on the same side as the planned adrenalectomy * Any individual deemed unsuitable for the study at the discretion of the investigator
Where it's running
-
Samsung Medical Center
Seoul, Gangnam-gu, South Korea Recruiting -
Seoul National University Hospital
Seoul, Jongno-gu, South Korea Recruiting
Study contacts
- Principal investigator: Su-jin Kim, M.D, Ph.D — Seoul National University Hospital
- Study coordinator: Seungho Lee, M.D
- Email: ganymedes10@gmail.com
- Phone: 82-10-8629-9209
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing catecholamine levels in blood during adrenal artery embolization for hypertension
This study is trying to see how blood pressure changes during a specific treatment for high blood pressure in people with primary aldosteronism and how it relates to certain hormones in the blood.
-
Endoscopic ultrasound-guided radiofrequency ablation for adrenal tumors in primary aldosteronism
This study is testing a new non-surgical treatment using ultrasound to see if it can help people with primary aldosteronism and adrenal tumors feel better compared to traditional surgery.
-
Kidney stiffness measured by ultrasound in hypertension and healthy volunteers
This study tests whether kidney stiffness measured by a non-invasive ultrasound method differs between people with high blood pressure and healthy individuals.
-
Inclisiran vs. Statin for Primary Aldosteronism
This trial tests whether inclisiran plus amlodipine works differently from a statin-based approach in people with primary aldosteronism and high blood pressure.
-
Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities
This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.
-
Metomidate PET-CT vs Usual Care for Primary Aldosteronism
This study tests whether [11C] metomidate PET-CT can help orient treatment for people with primary aldosteronism compared with the usual adrenal venous sampling approach.
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.