2022-501884-41-00已完成3 期
(21181) A multicenter, randomized, prospective double-blind, cross over Phase 3 study to evaluate the efficacy and safety of 0.04 mmol Gd/kg body weight of gadoquatrane for MRI in adults with known or suspected pathology of the central nervous system (CNS), compared to 0.1 mmol Gd/kg approved macrocyclic gadolinium-based contrast agents (GBCAs)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer AG
- 入组人数
- 186
- 试验地点
- 33
- 主要终点
- 3 visualization parameters (enhancement on a 4PS, delineation on a 4PS, morphology on a 3PS) assessed by separate blinded evaluation of combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR
研究概览
简要总结
To demonstrate non-inferior efficacy of gadoquatrane compared to macrocyclic GBCAs
研究设计
- 分配方式
- Randomized
- 主要目的
- Period 2
- 盲法
- Double (Subject, Investigator, Monitor, Analyst, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participant must be >= 18 years of age inclusive, at the time of signing the informed consent form
- •Participants with a clinical indication for a contrast-enhanced MRI (including MRA), with any approved standard of care macrocyclic GBCA with proven efficacy, safety and tolerability in clinical routine CE-MRI/MRA (gadobutrol, gadoterate meglumine/ gadoteric acid or gadoteridol) that is used at the site for the indication, for a known or suspected CNS pathology
- •Participants who can undergo study-related procedures, including 2 contrast-enhanced MRI examinations (one with gadoquatrane and one with a comparator macrocyclic GBCA), as per participant and Investigator's judgement
- •Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: Is a woman of nonchildbearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method during the study intervention period (at a minimum of 24 hours after the last dose of study intervention)
排除标准
- •Considered clinically unstable or has a concurrent/concomitant condition that may significantly alter image comparability between the 2 study MRIs or between study parameters (e.g. safety, PK parameters) or would not allow participation for the full planned study period, in the judgement of the investigator
- •Any contraindication to MRI examinations based on institution policy and investigator's clinical judgement (e.g. some metallic implants or active implants)
- •Participants presenting with severe renal insufficiency, defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2, derived from a serum or plasma creatinine sample obtained within 48 hours prior to the first contrast agent injection in the study.
- •Participants with acute kidney injury (i.e., acute renal failure), regardless of eGFR
- •History of moderate to severe allergic-like reaction to any GBCA
- •Bronchial asthma considered unstable or who have had recent modification to their medical therapy
- •Receipt of any contrast agent < 72 h prior to the study MRIs or planned to receive any contrast agent during the trial until 24 h +/- 4 h after the second study MRI
- •Planned or expected interventional diagnostic or therapeutic procedure (e.g. biopsy or surgery in the region of interest) or change in treatment (e.g. start of chemotherapy or antiangiogenic therapy, significant change in corticosteroids dose) that may significantly alter image comparability between the 2 MRIs or other study parameters (i.e. safety/AEs [e.g. confounding AEs or safety events due to surgery or chemotherapy], PK parameters), from the first study MRI up to 24 h after the second study MRI
- •Has received any investigational product within 30 days, or within 5 times half-life of the investigational product, whatever is shorter, prior to or concurrent with this study
- •Contraindications to the administration of macrocyclic GBCAs (depending on local product label), or history of adverse reaction to gadoquatrane
结局指标
主要结局
3 visualization parameters (enhancement on a 4PS, delineation on a 4PS, morphology on a 3PS) assessed by separate blinded evaluation of combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR
3 visualization parameters (enhancement on a 4PS, delineation on a 4PS, morphology on a 3PS) assessed by separate blinded evaluation of combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR
次要结局
- Sensitivity and specificity for the detection of lesions of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR
- 3 visualization parameters (enhancement on a 4PS, delineation on a 4PS, morphology on a 3PS) assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICR
- The overall diagnostic clinical value of combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, based on: i. the evaluation of diagnostic descriptive imaging features adapted from radiologic reporting standards (detection/exclusion of enhancing pathology; location, extent, and pattern of enhancement) on a 5PS (by the BICR and the Investigator; ii. the evaluation of patient management based on the diagnostic reporting recommendations (i.e., like
- Sensitivity and specificity for the detection of malignant lesions of combined pre- and post-gadoquatrane MRI and combined pre- and post-contrastcomparator MRI with macrocyclic GBCAs assessed by BICR and the investigator
- Describe the diagnoses from combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by the Investigator
- Confidence in diagnosis combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by BICR and by Investigator on 4PS
- Number of lesions seen on unenhanced MR image set and combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR
- Number of enhancing lesions seen on combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICR
- Number and intensity of treatment emergent adverse events, including number of serious adverse events, after administration of gadoquatrane compared to macrocyclic GBCAs reported by the investigator during 24 ±4h p.i.
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (33)
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