Primary Aldosteronism MedDRA version: 20.1 Level: PT Classification code 10036692 Term: Primary hyperaldosteronism System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Product Name: [68Ga]Ga-Pentixafor
Product Code: 9913
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: [68Ga]Ga-PentixaFor
CAS Number: 1345698-96-5
Other descriptive name: PENT
Sponsors
Radboudumc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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) - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 228 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 228
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -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) ;Secondary Objective: Step1 -Definitive quantitative criteria of [68Ga]Ga-PentixaFor uptake -In unilateral adrenalectomy, compare quantitative data in PET/CT imaging and CYP11B2 and CXCR4 staining -Outcomes based on PASO criteria Step2 -Outcomes after adrenalectomy of [68Ga]Ga-PentixaFor PET/CT vs AVS in subtyping patients with PA by using PASO criteria -Reproducibility of [68Ga]Ga-PentixaFor PET/CT -Intra- and inter-reader agreement of [68Ga]Ga-PentixaFor PET/CT for subtyping -Inter-observer agreement of [68Ga]Ga-PentixaFor PET/CT between imaging centers -In unilateral adrenalectomy, compare quantitative data in PET/CT imaging and CYP11B2 and CXCR4 staining -Cost effectiveness analysis of AVS versus [68Ga]Ga-PentixaFor PET/CT -Quality of life of [68Ga]Ga-PentixaFor PET/CT versus AVS -Rate of inconclusive results or failure of subtype diagnosis by [68Ga]Ga-PentixaFor PET/CT or AVS -Safety and intolerability -Image quality of [68Ga]Ga-PentixaFor PET/CT imaging;Primary end point(s): Step 1: Primary end point is a concordance between [68Ga]Ga-PentixaFor PET/CT and AVS of at least 50% Step 2: [68Ga]Ga-PentixaFor PET/CT results in less than 1 daily defined doses compared to AVS.;Timepoint(s) of evaluation of this end point: Step 1: We evaluate the concordance after the [68Ga]Ga-PentixaFor PET/CT and AVS is performed Step 2: We will evaluate the daily defined doses after 6 months of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Step 1: 1. To establish definitive quantitative criteria of [68Ga]Ga-PentixaFor uptake in unilateral and bilateral PA for SUVs, liver-to-lesion ratio and lesion-to-contralateral ratio. 2. In patients who receive unilateral adrenalectomy, compare quantitative data in PET/CT imaging between immunohistochemically (CYP11B2 and CXCR4 staining) diagnosed multinodular hyperplasia and solitary adenomas. 3. To assess biochemical and clinical outcomes based on PASO criteria (2) Step 2: 4. To asses biochemical and clinical outcomes after adrenalectomy of [68Ga]Ga-PentixaFor PET/CT imaging vs AVS in subtyping patients with PA by using the PASO criteria for clinical and biochemical outcome measures (complete, partial or absent) 5. To evaluate reproducibility of [68Ga]Ga-PentixaFor PET/CT by comparison of two [68Ga]Ga-PentixaFor PET/CT scans with an interval of 1-14 days in the first 10 patients undergoing [68Ga]Ga-PentixaFor PET/CT. 6. To assess intra- and inter-reader agreement of [68Ga]Ga-PentixaFor PET/CT for subtyping for each imaging center. 7. To analyze inter-observer agreement of [68Ga]Ga-PentixaFor PET/CT between the imaging centers in terms of subtyping. 8. In patients who receive unilateral adrenalectomy, compare quantitative data in PET/CT imaging between immunohistochemically (CYP11B2 and CXCR4 staining) diagnosed multinodular hyperplasia and solitary adenomas. 9. To perform cost effectiveness analysis of AVS versus [68Ga]Ga-PentixaFor PET/CT management. 10. To evaluate quality of life as assessed by EQ-5D-5L questionnaire and the Short Form health survey (SF36) of [68Ga]Ga-PentixaFor PET/CT versus AVS management 11. Determination of the rate of inconclusive results and/or failure of subtype diagnosis by [68Ga]Ga-PentixaFor PET/CT imaging or AVS. 12. To assess safety and intolerability. 13. To assess image quality of [68Ga]Ga-PentixaFor PET/CT imaging;Timepoint(s) of evaluation of this end point: 1. After the lateralization | — |
Countries
Netherlands
Contacts
Public ContactSecretary of Urology
Radboudumc
Outcome results
None listed