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)
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is a randomized controlled trial to assess the clinical utility of gallium-68 pentixafor PET/CT in the management of primary aldosteronism (PA). We aim to evaluate whether the addition of 68Ga-pentixafor PET/CT to standard adrenal venous sampling (AVS) improves surgical outcomes in patients with unilateral PA.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• Age ≥19 years
• Diagnosed with PA per 2016 Endocrine Society guidelines
• Underwent adrenal CT
• Signed informed consent
Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Seungho Lee, M.D
ganymedes10@gmail.com
82-10-8629-9209
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 90
Treatments
Experimental: AVS + 68Ga-pentixafor PET/CT (+ 11C-metomidate PET/CT)
Intervention:~Diagnostic Imaging: 68Ga-pentixafor PET/CT~With 68Ga-pentixafor PET/CT imaging added to AVS for lateralization Subset only: 11C-metomidate PET/CT (for research use only, not used in treatment decisions)
No_intervention: AVS only
No PET/CT Without 68Ga-pentixafor PET/CT imaging; AVS only (Gold standard)
Related Therapeutic Areas
Sponsors
Collaborators: Samsung Medical Center
Leads: Seoul National University Hospital