Primary aldosteronism
Conditions
Interventions
Sponsors
Radboudumc
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -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) -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
| Measure | Time frame |
|---|---|
| - To establish definitive quantitative criteria of [68Ga]Ga-PentixaFor uptake in unilateral and bilateral PA. - 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. - To assess the diagnostic accuracy of adrenal CT compared with [68Ga]Ga-PentixaFor PET/CT and AVS. - Cost analysis of AVS versus [68Ga]Ga-PentixaFor PET/CT management - 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) - To perform a safety analysis of [68Ga]-Pentixafor administration on clinical symptoms by Adverse Events outcomes. | — |
Contacts
Public ContactHossein Chaman Baz
Radboudumc
Outcome results
None listed