CXCR4-directed [68Ga]Ga-PentixaFor PET/CT vs AVS performance in a diagnoStic randomized Trial Ultimately comparing hypertenSion outcome in primary aldosteronism (CASTUS trial)
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 5
- 主要终点
- 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)
研究概览
简要总结
-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)
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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 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)
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)
次要结局
- 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. (step 1)
- 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. (step 1)
- To assess biochemical and clinical outcomes based on PASO criteria (step 1)
- 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). (step2)
- 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. (step 2)
- To assess intra- and inter-reader agreement of [68Ga]Ga-PentixaFor PET/CT for subtyping for each imaging center (step 2)
- To analyze inter-observer agreement of [68Ga]Ga-PentixaFor PET/CT between the imaging centers in terms of subtyping. (step 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. (step 2)
- To perform cost effectiveness analysis of AVS versus [68Ga]Ga-PentixaFor PET/CT management. (step 2)
- 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. (step 2)
- Determination of the rate of inconclusive results and/or failure of subtype diagnosis by [68Ga]Ga-PentixaFor PET/CT imaging or AVS. (step 2)
- To assess safety and intolerability. (step 2)
- To assess image quality of [68Ga]Ga-PentixaFor PET/CT imaging, using the SUVmean, SUVmax, and SUVpeak, lesion-to-liver ratio, contrast-to-noise ratio, and signal-to-noise ratio. (step 2)
- To assess biochemical and clinical outcomes in patients treated with antihypertensive drugs based on [68Ga]Ga-PentixaFor PET/CT imaging vs AVS in subtyping PA by using the PAMO criteria for clinical and biochemical outcome measures (complete, partial or absent) (currently unpublished data).
研究者
J. Deinum
Scientific
Stichting Radboud universitair medisch centrum