CXCR4-directed [68Ga]Ga-PentixaFor vs AVS performance in a diagnoStic randomized Trial Ultimately comparing hypertenSion outcome in primary aldosteronism (CASTUS trial)
- Conditions
- Primary aldosteronism
- Registration Number
- NL-OMON28682
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 265
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•The patient has a diagnosis of primary aldosteronism, confirmed by an elevated aldosterone/rennin ratio (ARR) and an intravenous salt-loading test (according to the Endocrine Society guidelines)(1)
•Age over 18 years at time of consent
•Signed informed consent
A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Refusal by the patients to undergo AVS, [68Ga]Ga-PentixaFor PET/CT, CT, or adrenalectomy
•Suspicion of familial hyperaldosteronism type 1 (FH-1) or type 3 (FH-3)
•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
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -To assess the concordance between [68Ga]Ga-PentixaFor PET/CT and AVS for identification and/or lateralization of APAs in patients with PA. (Step 1) <br>-To assess the quantity of antihypertensive medication after 1 year of follow-up needed to normalize blood pressure in patients who have been managed for PA according to either AVS or [68Ga]Ga-PentixaFor PET/CT. (Step 2)
- Secondary Outcome Measures
Name Time Method - To establish definitive quantitative criteria of [68Ga]Ga-PentixaFor uptake in unilateral and bilateral PA.<br>- In patients who receive an unilateral adrenalectomy, we compare [68Ga]Ga-PentixaFor uptake in PET/CT imaging between immunohistochemically (CYP11B2 staining) diagnosed multinodular hyperplasia and solitary adenomas.<br>- To assess the diagnostic accuracy of adrenal CT compared with [68Ga]Ga-PentixaFor PET/CT and AVS. <br>- Cost analysis of AVS versus [68Ga]Ga-PentixaFor PET/CT management<br>- Changes in quality of life assessed by a validated disease specific health-related Quality of Life (HRQoL) questionnaire and the Short Form health survey (SF36)(2, 3)<br>- To perform a safety analysis of [68Ga]-Pentixafor administration on clinical symptoms by Adverse Events outcomes.