MedPath

CXCR4-directed [68Ga]Ga-PentixaFor PET/CT vs AVS performance in a diagnoStic randomized Trial Ultimately comparing hypertenSion outcome in primary aldosteronism

Phase 2
Recruiting
Conditions
Aldosterone overproduction
Primary aldosteronis
10001353
10014710
Registration Number
NL-OMON49887
Lead Sponsor
Radboud Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
228
Inclusion Criteria

- The patient has a diagnosis of primary aldosteronism, confirmed by an
elevated aldosterone/renin ratio (ARR) and an intravenous salt-loading test
(according to the Endocrine Society guidelines)(1)
- 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

Exclusion Criteria

- Refusal by the patients to undergo AVS, [68Ga]Ga-PentixaFor PET/CT, CT, or
adrenalectomy
- Suspicion of familial hyperaldosteronism type 1, type 2, type 3 or type 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) kleiner dan 40 ml/min/1.73m²

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath