Using Gallium-68 Pentixafor PET-CT to improve surgery outcomes in primary aldosteronism
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)
NA · Seoul National University Hospital · NCT07027254
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 2 sites (Seoul, Gangnam-gu and 1 other locations) |
| Trial ID | NCT07027254 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul, Gangnam-gu and 1 other locations
- 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
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.
Conditions: Primary Aldosteronism, Secondary Hypertension, Aldosterone-Producing Adenoma, Idiopathic Hyperaldosteronism, Adrenalectomy, Primary aldosteronism, Gallium-68 pentixafor, 11C-metomidate