CXCR4-directed [68Ga]Ga-PentixaFor PET/CT vs AVS performance in a diagnoStic randomized Trial Ultimately comparing hypertenSion outcome in primary aldosteronism
- Conditions
- Primary aldosteronismMedDRA version: 20.1Level: PTClassification code: 10036692Term: Primary hyperaldosteronism Class: 100000004860Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]Therapeutic area: Diseases [C] - Hormonal diseases [C19]Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- CTIS2024-512628-12-00
- Lead Sponsor
- Stichting Radboud universitair medisch centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 228
The patient has a diagnosis of primary aldosteronism, confirmed by elevated aldosterone/renin ratio (ARR) and intravenous salt-loading test (according to the Endocrine Society guidelines), Patients who fall in the grey area” according to the Endocrine Society guidelines (1), will be discussed with all site investigators before inclusion to reach consensus on the diagnosis before inclusion., Age over 18 years at time of consent, Signed informed consent
Refusal by the patients to undergo AVS, [68Ga]Ga-PentixaFor PET/CT, CT, or adrenalectomy, Suspicion of familial hyperaldosteronism type 1 (FH-1), type 2 (FH-2), type 3 (FH-3), or type 4 (FH-4), Suspicion of adrenocortical carcinoma, Severe comorbidity potentially interfering with treatment or health-related quality of life, Requirement of medication interfering with the study protocol, Any medical condition present that in the opinion of the investigator will affect patients’ clinical status., Pregnancy or lactation, Estimated glomerular filtration rate (eGFR) < 40 ml/min/1.73m²
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