(21197) 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 any body region (except CNS), compared to 0.1 mmol Gd/kg approved macrocyclic gadolinium-based contrast agents (GBCAs) - 21197

Bayer AG0 个研究点目标入组 664 人2023年5月10日

适应症Contrast enhancement in magnetic resonance imaging for assessment of non-central nervous system pathology MedDRA version: 20.0Level: LLTClassification code: 10051174Term: Peripheral nerve disorder NOS Class: 10029205 MedDRA version: 22.1Level: PTClassification code: 10078223Term: Magnetic resonance imaging Class: 100000004848 MedDRA version: 22.1Level: LLTClassification code: 10029820Term: Nuclear magnetic resonance imaging gadolinium-enhanced Class: 10022891 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Contrast enhancement in magnetic resonance imaging for assessment of non-central nervous system pathology
发起方: Bayer AG
入组人数: 664
状态: 进行中（未招募）
最后更新: 去年

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2023年5月10日

结束日期

待定

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Bayer AG

入排标准

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, with known or suspected pathology of any body region, e.g. head and neck (except CNS), thorax (including e.g. breast, heart, chest wall), abdomen (including e.g. liver, kidney, pancreas), pelvis (including e.g. prostate, uterus, ovaries), extremities (including upper and lower., 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.