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一项研究，比较钆喹啉与现有 MRI 造影剂对患有任何已知或疑似身体问题（大脑或脊髓相关问题除外）的患者的疗效及其安全性 (Quanti OBR)

2026年7月29日 更新者：Bayer

一项多中心、随机、前瞻性双盲、交叉 3 期研究，旨在评估 0.04 mmol Gd/kg 体重的钆喹啉用于 MRI 对已知或疑似任何身体部位（中枢神经系统除外）病理的成人的疗效和安全性，与 0.1 mmol Gd/kg 批准的大环钆基造影剂 (GBCA) 相比

研究人员正在寻找一种更好的方法来帮助患有任何已知或疑似问题（大脑或脊髓相关问题除外）并计划进行“对比增强”磁共振成像 (MRI) 的人们。

医生使用 MRI 来创建身体内部的详细图像，以识别健康问题。 有时，医生需要将造影剂注射到患者的静脉中以进行“对比增强”MRI (CE-MRI)。 此类 CE-MRI 可能有助于识别某些健康问题或改进评估。

MRI 中常用的造影剂是钆基造影剂 (GBCA)。 GBCA 含有一种称为钆 (Gd) 的“稀土”元素。 Gadoquatrane 是一种正在开发的新型造影剂，每次 CE-MRI 所需的 Gd 量较低。

本研究的主要目的是了解使用钆季铵的 CE-MRI 扫描是否与目前使用的 GBCA 一样有效。 研究人员将比较钆季铵-MRI 扫描和目前使用的 GBCA-MRI 扫描检测已知或可疑问题（大脑或脊髓相关问题除外）的能力。

参与者将接受 2 次 MRI 扫描，其中一项使用钆喹啉，另一项使用当前使用的 GBCA。 两种造影剂都将被注射到静脉中。

每位参与者将参与研究 6 至 42 天，最多看医生 7 次。

在研究开始或研究期间，医生及其研究团队将：

  • 采集血液和尿液样本
  • 做身体检查
  • 检查血压和心率
  • 检查研究中获得的 MRI 扫描并做出诊断
  • 向参与者询问他们的感受以及他们遇到的不良事件。

不良事件是参与者在研究期间出现的任何医疗问题。 医生会跟踪所有不良事件，无论他们认为这是否与研究治疗相关。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

410

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100730
        • Beijing Hospital
      • Beijing、Beijing Municipality、中国、100020
        • Beijing Chaoyang Hospital, Capital Medical University
      • Beijing、Beijing Municipality、中国、100034
        • Peking University First Hospital - Oncology Department
    • Guangdong
      • Guangzhou、Guangdong、中国、510515
        • Nanfang Hospital, Southern Medical University
      • Guangzhou、Guangdong、中国、510630
        • The First Affiliated Hospital of Jinan University
    • Jiangsu
      • Huai'an、Jiangsu、中国、223300
        • Huai'an First People's Hospital, Nanjing Medical University
      • Nanjing、Jiangsu、中国、210009
        • Zhongda Hospital Southeast University
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • West China Hospital Sichuan University
    • Zhejiang
      • Wenzhou、Zhejiang、中国、325000
        • The First Affiliated Hospital of Wenzhou Medical University
  • 保加利亚
      • Sofia、保加利亚、1784
        • University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department
      • Sofia、保加利亚、1407
        • Acibadem City Clinic | University Multiprofile Hospital for Active Treatment Tokuda - Radiology Department
    • Pleven Province
      • Pleven、Pleven Province、保加利亚、5809
        • University Multiprofile Hospital for Active Treatment Dr Georgi Stranski Pleven | Surgery Department
    • Plovdiv Province
      • Plovdiv、Plovdiv Province、保加利亚、4002
        • Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan
      • Plovdiv、Plovdiv Province、保加利亚、4002
        • University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department
    • Sofia City Province
      • Sofia、Sofia City Province、保加利亚、1431
        • University Multiprofile Hospital For Active Treatment 'Alexandrovska' EAD
      • Sofia、Sofia City Province、保加利亚、1431
        • University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD
      • Sofia、Sofia City Province、保加利亚、1431
        • University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Radiology Department
  • 加拿大
    • Quebec
      • Montreal、Quebec、加拿大、H4J 1C5
        • Hôpital du Sacré-Cœur de Montréal | Radiology
  • 匈牙利
      • Debrecen、匈牙利、4032
        • Debreceni Egyetem Klinikai Kozpont - Onkologiai Klinika
      • Pécs、匈牙利、7625
        • Pécsi Tudományegyetem Klinikai Központ
      • Szeged、匈牙利、6726
        • Trial Pharma Kft. Szeged
  • 土耳其（türkiye）
      • Erzincan、土耳其（türkiye）、24100
        • Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji
      • Istanbul、土耳其（türkiye）、34098
        • Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
      • Istanbul、土耳其（türkiye）、34093
        • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
      • Istanbul、土耳其（türkiye）、34010
        • Koc Universitesi Tip Fakultesi - Radyoloji
      • Samsun、土耳其（türkiye）、55139
        • Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi
  • 德国
      • Essen、德国、45147
        • Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21197
    • Baden-Wurttemberg
      • Freiburg im Breisgau、Baden-Wurttemberg、德国、79106
        • Uniklinik Freiburg / Radiologie
    • Lower Saxony
      • Göttingen、Lower Saxony、德国、37075
        • Universitätsmedizin Göttingen - Institut für Diagnostische und Interventionelle Radiologie
    • North Rhine-Westphalia
      • Bonn、North Rhine-Westphalia、德国、53127
        • Uniklinik Bonn / Radiologie
    • Saxony
      • Leipzig、Saxony、德国、04289
        • Helios Herzzentrum Leipzig - Abteilung für diagnostische und interventionelle Radiologie
    • State of Berlin
      • Berlin、State of Berlin、德国、13125
        • Helios Klinikum Berlin-Buch - Klinik für Kardiologie - Kardio MRT
  • 意大利
    • Lazio
      • Rome、Lazio、意大利、00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Rome、Lazio、意大利、00189
        • Azienda Ospedaliero-Universitaria Sant'Andrea - UOC Radiologia
    • Lombardy
      • Brescia、Lombardy、意大利、25123
        • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia - Radiologia Diagnostica 1
    • Veneto
      • Treviso、Veneto、意大利、31100
        • AULSS N. 2 Marca Trevigiana_Ospedale di Treviso - UOC Radiologia
  • 捷克语
      • Ostrava、捷克语、708 00
        • Fakultní nemocnice Ostrava - Radiodiagnostický ústav
      • Pardubice、捷克语、530 03
        • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice
      • Pilsen、捷克语、32300
        • Fakultni nemocnice Plzen - Lochotin
      • Prague、捷克语、12808
        • Vseobecna fakultni nemocnice v Praze
      • Praha 4 - Krc、捷克语、140 00
        • Fakultní Thomayerova nemocnice - klinicko-farmakologická jednotka
    • South Moravian
      • Brno、South Moravian、捷克语、625 00
        • Fakultní nemocnice Brno - Klinika radiologie a nukleární medicíny
  • 日本
    • Fukuoka
      • Fukuoka、Fukuoka、日本、811-0213
        • Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital
      • Kitakyushu、Fukuoka、日本、806-8501
        • JCHO Kyushu Hospital
      • Kitakyushu、Fukuoka、日本、807-8556
        • Hospital of the University of Occupational and Environmental Health, Japan
    • Hokkaido
      • Hakodate、Hokkaido、日本、040-8585
        • Hakodate Central General Hospital
      • Sapporo、Hokkaido、日本、060-8648
        • Hokkaido University Hospital
    • Hyōgo
      • Nishinomiya、Hyōgo、日本、662-0918
        • Hyogo Prefectural Nishinomiya Hospital
    • Ishikawa-ken
      • Hakusan、Ishikawa-ken、日本、924-8588
        • Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office
      • Kanazawa、Ishikawa-ken、日本、920-8650
        • National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office
    • Kagawa-ken
      • Takamatsu、Kagawa-ken、日本、760-0017
        • Takamatsu Red Cross Hospital
    • Osaka
      • Kishiwada、Osaka、日本、596-0042
        • Kishiwada Tokushukai Hospital
      • Osaka、Osaka、日本、534-0021
        • Local Incorporated Administrative Agency Osaka City Hospital Organization Osaka City General Hospital
    • Tottori
      • Yonago、Tottori、日本、683-8605
        • Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
    • Yamaguchi
      • Shimonoseki、Yamaguchi、日本、752-8510
        • National Hospital Organization Kanmon Medical Center
  • 法国
      • Dijon、法国、21079
        • Centre Hospitalier Universitaire de Dijon
    • Auvergne-Rhône-Alpes
      • Bron、Auvergne-Rhône-Alpes、法国、69500
        • Hospices Civils de Lyon
    • Pays de la Loire Region
      • Angers、Pays de la Loire Region、法国、49933
        • Centre Hospitalier Universitaire - Angers
    • Île-de-France Region
      • Paris、Île-de-France Region、法国、75018
        • Hôpital Bichat Claude Bernard - Service de radiologie
  • 波兰
      • Bialystok、波兰、15-402
        • NZOZ Kendron
      • Gdansk、波兰、80-214
        • Uniwersyteckie Centrum Kliniczne
      • Lodz、波兰、91-053
        • Centra Medyczne Medyceusz
      • Warsaw、波兰、01-785
        • Centrum Medycznym Gamma
  • 瑞典
    • Stockholm County
      • Stockholm、Stockholm County、瑞典、141 86
        • Karolinska Universitetssjukhuset - Huddinge - Radiologi
    • Uppsala County
      • Uppsala、Uppsala County、瑞典、751 85
        • Akademiska sjukhuset i Uppsala
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35233
        • UAB Hospital - Radiology
    • California
      • Indian Wells、California、美国、92210
        • Halo Diagnostics - Indian Wells
      • Orange、California、美国、92868
        • UC Irvine Medical Center
    • Connecticut
      • Farmington、Connecticut、美国、06032
        • University of Connecticut Health Center
    • Florida
      • Miami、Florida、美国、33165
        • Biogenix Molecular, LLC
    • Missouri
      • Columbia、Missouri、美国、65212
        • University of Missouri Hospital and Clinic - Neuroradiology
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke University School of Medicine - Early Phase Research Unit - Neurology
    • Pennsylvania
      • Hershey、Pennsylvania、美国、17033
        • Pennsylvania State University College of Medicine
    • Texas
      • Houston、Texas、美国、77030
        • Houston Methodist Hospital - Cardiology
  • 英国
    • Nottinghamshire
      • Nottingham、Nottinghamshire、英国、NG7 2UH
        • Nottingham University Hospital
    • Scotland
      • Glasgow、Scotland、英国、G51 4TF
        • Queen Elizabeth University Hospital
    • Wales
      • Cardiff、Wales、英国、CF14 4XW
        • Cardiff and Vale University Health Board |University Hospital of Wales - Clinical Research Facility
  • 阿根廷
    • Buenos Aires
      • Lomas de Zamora, Buenos Aires、Buenos Aires、阿根廷、B1832BRQ
        • Fundacion Cientifica del Sur | Centro de Lomas de Zamora - Imaging Interventionism Department
    • Ciudad Auton. de Buenos Aires
      • CABA、Ciudad Auton. de Buenos Aires、阿根廷、C1426
        • Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes
      • Ciudad Autonoma de Buenos Aire、Ciudad Auton. de Buenos Aires、阿根廷、C1115AAB
        • Sanatorio Otamendi | Imaging Diagnostic Center
      • Ciudad Autonoma de Buenos Aire、Ciudad Auton. de Buenos Aires、阿根廷、C1425BEE
        • Centro de Diagnostico Enrique Rossi | Departamento de Investigacion Clínica
    • Córdoba Province
      • Córdoba、Córdoba Province、阿根廷、X5000JHQ
        • Sanatorio Allende | Departamento de Investigación Clínica
      • Córdoba、Córdoba Province、阿根廷、X5004FHP
        • Clinica Universitaria Reina Fabiola | Consultorios Externos
  • 韩国
    • Gyeonggi-do
      • Suwon、Gyeonggi-do、韩国、16499
        • Ajou University Hospital | Radiology
    • Seoul Teugbyeolsi
      • Seoul、Seoul Teugbyeolsi、韩国、03080
        • Seoul National University Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  • 签署知情同意书时，参与者必须年满 18 岁（含）
  • 具有对比增强 MRI（包括磁共振血管造影 [MRA]）临床指征的参与者，具有任何经批准的大环 GBCA 护理标准，并在临床常规 CE-MRI/MRA 中证明其有效性、安全性和耐受性（钆布醇、钆酸葡甲胺/钆特酸或钆特醇）用于适应症部位，具有已知或可疑的任何身体部位的病理学特征，例如，头部和颈部（中枢神经系统 [CNS] 除外）、胸部（包括例如颈部） 胸部、心脏、胸壁）、腹部（包括例如腹部） 肝脏、肾脏、胰腺）、骨盆（包括例如 前列腺、子宫、卵巢）、四肢（包括上、下。
  • 根据参与者和研究者的判断，可以接受与研究相关的程序的参与者，包括 2 次对比增强 MRI 检查（一项使用钆喹啉，一项使用比较剂大环 GBCA）
  • 女性参与者使用的避孕措施应符合当地有关参与临床研究的避孕方法的规定。 如果女性参与者未怀孕或未哺乳，并且满足以下条件之一，则有资格参加： 是一名不具有生育潜力的女性 (WONCBP) 或 是一名具有生育潜力的女性 (WOCBP)，并且在怀孕期间使用了可接受的避孕方法研究干预期（最后一次研究干预后至少 24 小时）。

排除标准：

  • 被认为临床不稳定或具有并发/伴随病症，可能会显着改变 2 个研究 MRI 之间或研究参数之间的图像可比性（例如， 安全性、药代动力学 [PK] 参数）或根据研究者的判断不允许参与整个计划研究期
  • 患有严重肾功能不全的参与者，定义为估计肾小球滤过率 (eGFR) < 30 mL/min/1.73 m^2，源自研究中第一次注射造影剂前 48 小时内获得的血清肌酐样本
  • 患有急性肾损伤（即急性肾衰竭）的参与者，无论 eGFR 是多少
  • 对任何 GBCA 有中度至重度过敏样反应史
  • 支气管哮喘被认为不稳定和/或需要治疗
  • 在研究 MRI 之前 < 72 小时内接受任何造影剂，或计划在试验期间接受任何造影剂直至第二次研究 MRI 后 24 小时 +/- 4 小时
  • 计划或预期的介入诊断或治疗程序（例如 感兴趣区域的活检或手术）或改变治疗（例如 化疗或抗血管生成治疗的开始、皮质类固醇剂量的显着变化）可能会显着改变 2 个 MRI 之间的图像可比性或其他研究参数（即， 安全/不良事件 [AE] [例如 因手术或化疗导致的混杂 AE 或安全事件]、PK 参数），从第一个研究 MRI 到第二个研究 MRI 后 24 小时
  • 在本研究之前或同时，在 30 天内或在研究产品半衰期的 5 倍之内（以较短者为准）接受过任何研究产品
  • 服用大环 GBCA 的禁忌症（取决于当地产品标签）或对钆喹啉有不良反应史
  • 根据机构政策和研究者的临床判断存在任何 MRI 检查禁忌症（例如 一些金属植入物或有源植入物）

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：钆喹啉 - 批准的大环 GBCA
参与者将在第 1 阶段的 MRI 期间接受 1 次静脉注射钆喹啉，然后在第 2 阶段的 MRI 期间静脉注射任何经批准的大环 GBCA。
药品：钆喹烷 (BAY1747846)
0.04 mmol Gd/kg体重，静脉注射溶液，单剂量
药品：钆布醇
批准的护理标准大环 GBCA，0.1 mmol Gd/kg 体重，静脉注射溶液，单剂量
药品：钆葡甲胺
批准的护理标准大环 GBCA，0.1 mmol Gd/kg 体重，静脉注射溶液，单剂量
其他名称：
  • 钆特酸
药品：钆特醇
批准的护理标准大环 GBCA，0.1 mmol Gd/kg 体重，静脉注射溶液，单剂量
实验性的：批准的大环 GBCA - 钆喹啉
参与者将在第 1 阶段的 MRI 期间接受一次静脉注射任何经批准的大环 GBCA，然后在第 2 阶段的 MRI 期间静脉注射 1 次钆喹啉。
药品：钆喹烷 (BAY1747846)
0.04 mmol Gd/kg体重，静脉注射溶液，单剂量
药品：钆布醇
批准的护理标准大环 GBCA，0.1 mmol Gd/kg 体重，静脉注射溶液，单剂量
药品：钆葡甲胺
批准的护理标准大环 GBCA，0.1 mmol Gd/kg 体重，静脉注射溶液，单剂量
其他名称：
  • 钆特酸
药品：钆特醇
批准的护理标准大环 GBCA，0.1 mmol Gd/kg 体重，静脉注射溶液，单剂量

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Visualization Parameter Contrast Enhancement Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR
大体时间：1 day procedure
Contrast Enhancement was assessed on a 4-point scale (1/No: not enhanced, 2/Moderate: weakly enhanced, 3/Good: clearly enhanced, 4/Excellent: clearly and brightly enhanced). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging
1 day procedure
Visualization Parameter Delineation Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR
大体时间：1 day procedure
Delineation was assessed on a 4-point scale (1/No: no or unclear delineation, 2/Moderate: some aspects of delineation, 3/Good: almost clear but not complete, 4/Excellent: clear and complete delineation). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging
1 day procedure
Visualization Parameter Morphology Assessed by Separate Blinded Evaluation of Unenhanced and Combined Pre- and Post-gadoquatrane MRI, by a BICR
大体时间：1 day procedure
Morphology was assessed on a 3-point scale (1/Poor: no or poorly evaluable, 2/Moderate: partially evaluable, 3/Good: sufficiently evaluable). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging
1 day procedure

次要结果测量

结果测量
措施说明
大体时间
Visualization Parameter Contrast 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
大体时间：Two MRI examinations with an interval of 3-14 days between them
Contrast Enhancement was assessed on a 4-point scale (1/No: not enhanced, 2/Moderate: weakly enhanced, 3/Good: clearly enhanced, 4/Excellent: clearly and brightly enhanced). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
Two MRI examinations with an interval of 3-14 days between them
Visualization Parameter Delineation 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
大体时间：Two MRI examinations with an interval of 3-14 days between them
Delineation was assessed on a 4-point scale (1/No: no or unclear delineation, 2/Moderate: some aspects of delineation, 3/Good: almost clear but not complete, 4/Excellent: clear and complete delineation). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
Two MRI examinations with an interval of 3-14 days between them
Visualization Parameter Morphology 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
大体时间：Two MRI examinations with an interval of 3-14 days between them
Morphology was assessed on a 3-point scale (1/Poor: no or poorly evaluable, 2/Moderate: partially evaluable, 3/Good: sufficiently evaluable). BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agents
Two MRI examinations with an interval of 3-14 days between them
Sensitivity 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
大体时间：Two MRI examinations with an interval of 3-14 days between them
Sensitivity for the detection of lesions was evaluated by blinded independent central review (BICR) readers using combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. A lesion was defined as a localized, clinically relevant pathological change in a tissue due to injury or disease. In the context of imaging, it was defined as the localization of a pathology which might have been visualized on the MRI. The result from the BICR was then matched with the information from the composite Standard of Truth (cSoT). The cSoT was determined up to 4 weeks after second study related MRI based on the totality of the available clinical information by the referring physician.
Two MRI examinations with an interval of 3-14 days between them
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
大体时间：Two MRI examinations with an interval of 3-14 days between them
Specificity for the detection of lesions was evaluated by blinded independent central review (BICR) readers using combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. A lesion was defined as a localized, clinically relevant pathological change in a tissue due to injury or disease. In the context of imaging, it was defined as the localization of a pathology which might have been visualized on the MRI. The result from the BICR was then matched with the information from the composite Standard of Truth (cSoT). The cSoT was determined up to 4 weeks after second study related MRI based on the totality of the available clinical information by the referring physician.
Two MRI examinations with an interval of 3-14 days between them
The Overall Diagnostic Clinical Value of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs
大体时间：Two MRI examinations with an interval of 3-14 days between them
Overall diagnostic clinical value is based on the three descriptive imaging features; enhancement location, extension and pattern and is measured on a 5 point scale: 1- no diagnostic clinical value; 2-poor diagnostic clinical value; 3- moderate diagnostic clinical value; 4- good diagnostic clinical value; 5-excellent diagnostic clinical value. BICR = Blinded independent central reviewer.
Two MRI examinations with an interval of 3-14 days between them
Sensitivity for the Detection of Malignant Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs Assessed by BICR and the Investigator
大体时间：Two MRI examinations with an interval of 3-14 days between them
Sensitivity for the detection of malignant lesions was evaluated by blinded independent central review (BICR) readers and by the investigator/designee using combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Lesion assessments were compared with the composite Standard of Truth (cSoT), and sensitivity with corresponding 95% confidence intervals was calculated.
Two MRI examinations with an interval of 3-14 days between them
Specificity for the Detection of Malignant Lesions of Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs Assessed by BICR and the Investigator
大体时间：Two MRI examinations with an interval of 3-14 days between them
Specificity for the detection of malignant lesions was evaluated by blinded independent central review (BICR) readers and by the investigator/designee using combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Lesion assessments were compared with the composite Standard of Truth (cSoT), and specificity with corresponding 95% confidence intervals was calculated.
Two MRI examinations with an interval of 3-14 days between them
Number of Cases With Concordance Between Final Diagnosis and MRI Diagnosis From Combined pre-and Post- Gadoquatrane MRI and Combined Pre- and Post- Comparator MRI With Macrocyclic GBCAs, as Assessed by the Investigator
大体时间：Two MRI examinations with an interval of 3-14 days between them
The investigator or designee, who remained blinded to the contrast agent used in the image set, was asked for the diagnosis based on the combined pre- and post-contrast MRI image sets for each period, which was compared to the composite Standard of Truth (cSoT). The cSoT was determined up to 4 weeks after second study related MRI based on the totality of the available clinical information by the referring physician. Concordance between the MRI-based diagnosis and the final clinical diagnosis was evaluated, and the number of cases with matching and non-matching diagnoses was summarized.
Two MRI examinations with an interval of 3-14 days between them
Confidence in Diagnosis Combined Pre- and Post- Gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs by BICR and by Investigator
大体时间：Two MRI examinations with an interval of 3-14 days between them
Confidence in diagnosis was assessed by blinded independent central review (BICR) readers and the investigator to determine the level of certainty in the assigned diagnosis based on combined pre- and post-contrast MRI image sets for gadoquatrane and comparator macrocyclic GBCAs. Confidence was scored using a 4-point scale (1 = Not confident, 2 = Somewhat confident, 3 = Confident, 4 = Very confident), and mean scores with standard deviation are reported.
Two MRI examinations with an interval of 3-14 days between them
Number of Lesions Seen on Unenhanced MR Image Sets and Combined Pre- and Post-gadoquatrane MRI and Combined Pre- and Post-comparator MRI With Macrocyclic GBCAs, by a BICR
大体时间：Two MRI examinations with an interval of 3-14 days between them
Total number of lesions across all participants was counted by 3 blinded independent central readers on the unenhanced (pre-contrast) and combined pre- and post-contrast gadoquatrane and comparator MR image set.
Two MRI examinations with an interval of 3-14 days between them
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
大体时间：Two MRI examinations with an interval of 3-14 days between them
The total number of contrast-enhanced lesions for each contrast- enhanced image set (gadoquatrane and comparators-enhanced MR images) was evaluated by two of the blinded independent central readers.
Two MRI examinations with an interval of 3-14 days between them
Number of Participants With Treatment Emergent Adverse Events, Including Number of Serious Adverse Events, After Administration of Gadoquatrane Compared to Macrocyclic GBCAs Reported by the Investigator
大体时间：Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs
Treatment-emergent adverse events (TEAEs), including serious adverse events (TESAEs), are defined as events occurring from the start of study intervention until follow-up (24 ± 4 hours post-injection.
Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs
Number of Participants With Treatment Emergent Adverse Events, Including Number of Serious Adverse Events, Per Intensity After Administration of Gadoquatrane Compared to Macrocyclic GBCAs Reported by the Investigator
大体时间：Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs
Treatment-emergent (serious) AEs are defined as events occurring from the start of study intervention until follow-up (24 ± 4 hours post-injection). Participants with at least one treatment-emergent adverse event are counted once and categorized according to the maximum intensity of their adverse events (mild, moderate, or severe), as assessed by the investigator.
Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs

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研究主要日期

学习开始 (实际的)

2023年7月24日

初级完成 (实际的)

2024年5月31日

研究完成 (实际的)

2024年6月1日

研究注册日期

首次提交

2023年6月14日

首先提交符合 QC 标准的

2023年6月14日

首次发布 (实际的)

2023年6月23日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年6月1日

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与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 21197
  • 2022-501885-24-00 (其他标识符：CTIS (EU))

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本研究数据的可用性稍后将根据拜耳对 EFPIA/PhRMA“负责任的临床试验数据共享原则”的承诺来确定。 这涉及数据访问的范围、时间点和过程。 因此，拜耳承诺根据合格研究人员的要求，分享患者级临床试验数据、研究级临床试验数据以及美国和欧盟批准的药物和适应症患者临床试验方案，以进行合法研究。 这适用于2014年1月1日或之后欧盟和美国监管机构批准的新药和适应症的数据。

感兴趣的研究人员可以使用 www.vivli.org 请求访问匿名患者级数据和临床研究的支持文件以进行研究。 门户网站的会员部分提供了有关拜耳上市研究标准的信息以及其他相关信息。

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研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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