Pilot study for the evaluation of [68Ga]Ga-PentixaFor PET imaging for the identification of unilateral adrenal secretion of ALdosterON in patients with primary aldosteronism.
- Conditions
- Primary aldosteronism, Primary aldosteronismMedDRA version: 20.1Level: PTClassification code: 10036692Term: Primary hyperaldosteronism Class: 100000004860Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-505507-22-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Age = 18 years old, Signed written informed consent, French Social Security affiliation, For child-bearing aged women, efficient contraception, Diagnosis of primary aldosteronism: -With or without adrenal nodule on morphological imaging (CT or Magnetic Resonance Imaging) -With unilateral or bilateral aldosterone secretion confirmed by invasive AVS
Pregnant or breastfeeding women, Patient under legal protection (guardianship), Contraindication to the PET-CT, Contraindication to the injection of [68Ga]Ga-PentixaFor, Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable, Patient on AME (state medical aid) (unless exemption from affiliation), Completed group: if the expected number of patients has been reached (15 patients) in the corresponding group of patients (with lateralized or non-lateralized PA).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method