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CXCR4-directed [68Ga]Ga-PentixaFor PET/CT vs AVS performance in a diagnoStic randomized Trial Ultimately comparing hypertenSion outcome in primary aldosteronism (CASTUS trial)
EU CTIS ID: 2024-512628-12-00
What this study is testing
-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 non-inferiority in terms of clinical outcomes of [68Ga]Ga-PentixaFor PET/CT imaging vs. AVS in subtyping of patients with PA randomized to either [68Ga]Ga-PentixaFor PET/CT imaging or AVS confirmed by the surrogate Standard of Truth (SoT) daily defined doses (DDD) in patients after 6 months follow-up. (Step 2)
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.