Trial Condition(s):
Contrast enhancement in magnetic resonance imaging, Non-central nervous system pathology
A study to compare how well gadoquatrane works and its safety with an already available contrast agent for MRI in people with any known or suspected problems of the body (except brain or spinal cord-related problems) (Quanti OBR)
Bayer Identifier:
21197
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
2022-501885-24-00
Trial Purpose
Researchers are looking for a better way to help people with any known or suspected problems (except brain or spinal cord-related problems) scheduled for a “contrast-enhanced” Magnetic Resonance Imaging (MRI).
MRI is used by doctors to create detailed images of the inside of the body to identify health problems. Sometimes doctors need to inject contrast agent into a patient’s vein to perform a so called “contrast-enhanced” MRI (CE-MRI). Such CE-MRI examinations may support doctors to identify certain health problems or improve the evaluation.
The contrast agents commonly used in MRI are gadolinium-based contrast agents (GBCAs). GBCAs contain a “rare earth” element called gadolinium (Gd). Gadoquatrane is a new contrast agent under development with a lower amount of Gd needed per CE-MRI.
The main purpose of this study is to learn whether CE-MRI scans with gadoquatrane work better than MRI scans without the use of a contrast agent (GBCA). The researchers will compare the ability to detect known or suspected problems (except brain or spinal cord-related problems) with gadoquatrane-MRI scans to plain-MRI scans without the use of a contrast agent.
The participants will undergo 2 MRI scans, one with gadoquatrane and one with currently used GBCA. Both contrast agents will be injected into the vein.
Each participant will be in the study for between 6 and 42 days with up to 7 doctor visits.
At the start or during the study, the doctors and their study team will:
• take blood and urine samples
• do physical examinations
• check blood pressure and heart rate
• review the MRI scans obtained in the study and decide on the diagnosis
• ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
Inclusion Criteria
- 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 magnetic resonance angiography [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 central nervous system [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).
Exclusion Criteria
- 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, pharmacokinetics [PK] parameters) or would not allow participation for the full planned study period, in the judgement of the investigator - 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/adverse events [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 - Any contraindication to MRI examinations based on institution policy and investigator's clinical judgement (e.g. some metallic implants or active implants)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations The First Affiliated Hospital of Wenzhou Medical University Wenzhou, China, 325000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The First Affiliated Hospital of Jinan University Guangzhou, China, 510630 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nanfang Hospital, Southern Medical University Guangzhou, China, 510515 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro de Diagnóstico Dr. Enrique Rossi Buenos Aires, Argentina, C1425BEE | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sanatorio Allende | Departamento de Investigación Clínica Córdoba, Argentina, X5000JHQ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fundacion Cientifica del Sur | Centro de Lomas de Zamora - Imaging Interventionism Department Lomas de Zamora, Buenos Aires, Argentina, B1832BRQ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sanatorio Otamendi | Imaging Diagnostic Center Buenos Aires, Argentina, C1115AAB | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clinica Universitaria Reina Fabiola | Consultorios Externos Cordoba, Argentina, X5004FHP | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Instituto Alexander Fleming | Sede Central - Departamento de Diagnostico por Imagenes CABA, Argentina, C1426 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Hospital Beijing, China, 100730 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Beijing Chaoyang Hospital, Capital Medical University Beijing, China, 100020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 3080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Konkuk University Medical Center Seoul, South Korea, 5030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ajou University Hospital Suwon, South Korea, 443-721 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centrum Medyczne HCP Sp. z o.o. Poznan, Poland, 61-485 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniwersyteckie Centrum Kliniczne Gdansk, Poland, 80-214 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centra Medyczne Medyceusz Lodz, Poland, 91-053 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen Elizabeth University Hospital Glasgow, United Kingdom, G51 4TF | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospital of Wales Cardiff, United Kingdom, CF14 4XW | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nottingham University Hospital Nottingham, United Kingdom, NG7 2UH | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Trial Pharma Kft. Szeged Szeged, Hungary, 6726 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pecsi Tudomanyegyetem Klinikai Kozpont Pecs, Hungary, 7625 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Plzen - Lochotin Plzen, Czech Republic, 32300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vseobecna fakultni nemocnice v Praze Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Ostrava Ostrava, Czech Republic, 708 52 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni Thomayerova Nemocnice Prague, Czech Republic, 140 59 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Brno Brno, Czech Republic, 625 00 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice Pardubice, Czech Republic, 530 03 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Alexandrovska EAD Sofia, Bulgaria, 1431 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Sant'Andrea Roma, Italy, 00189 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Spedali Civili di Brescia Brescia, Italy, 25123 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ULSS2 Marca Trevigiana Treviso, Italy, 31100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Alabama at Birmingham Birmingham, United States, 35233 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Missouri Hospital and Clinic – Neuroradiology Columbia, United States, 65212 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Connecticut Health Center Farmington, United States, 06030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UC Irvine Medical Center Orange, United States, 92868 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Halo Diagnostics Indian Wells, United States, 92210 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pennsylvania State University College of Medicine Hershey, United States, 17033 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Duke University School of Medicine Durham, United States, 27710 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Houston Methodist Hospital Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Boston Medical Center Boston, United States, 02118 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northwestern University Chicago, United States, 60611 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Hospital Organization Kanazawa Medical Center | Clinical Trial Management Office Kanazawa, Japan, 920-8650 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Public Central Hospital of Matto Ishikawa | Clinical Trial Management Office Hakusan, Japan, 924-8588 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Osaka City General Hospital Osaka, Japan, 534-0021 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hyogo Prefectural Nishinomiya Hospital Nishinomiya, Japan, 662-0918 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations National Hospital Organization Kanmon Medical Center Shimonoseki, Japan, 752-8510 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Takamatsu Red Cross Hospital Takamatsu, Japan, 760-0017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Social Medical Corporation the Chiyukai foundation Fukuoka Wajiro Hospital Fukuoka, Japan, 811-0213 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital of the University of Occupational and Environmental Health, Japan Kitakyushu, Japan, 807-8556 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations JCHO Kyushu Hospital Kitakyushu, Japan, 806-8501 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kishiwada Tokushukai Hospital Kishiwada, Japan, 596-0042 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Japan Organization of Occupational Health and Safety Sanin Rosai Hospital Yonago, Japan, 683-8605 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations West China Hospital Sichuan University Chengdu, China, 610041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Karolinska University Hospital Huddinge Radiology Stockholm, Sweden, 14186 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Multiprofile Hospital for Active Treatment Prof. Dr. Alexander Chirkov EAD Sofia, Bulgaria, 1431 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Multiprofile Hosp. for Active Treat. Sveti Ivan Sofia, Bulgaria, 1431 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Acibadem City Clinic | University Multiprofile Hospital for Active Treatment Tokuda - Radiology Department Sofia, Bulgaria, 1407 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Radiology Department Sofia, Bulgaria, 1784 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Multiprofile Hospital for Active Treatment Sveti Georgi | Base II - Imaging Diagnostic Department Plovdiv, Bulgaria, 4002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiprofile Hospital for Active Treatment Central Onco Hospital | Independent Medical Diagnostic Laboratory Mediscan Plovdiv, Bulgaria, 4002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Peking University First Hospital Beijing, China, 100034 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital du Sacre-Coeur de Montreal Montreal, Canada, QC H4J 1C5 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St.Joseph's Health Care-London London, Canada, N6G 2M3 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Huai'an First People's Hospital, Nanjing Medical University Huai'An, China, 223300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zhongda Hospital Southeast University Nanjing, China, 210009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Binali Yildirim Universitesi Mengucek Gazi EAH - Radyoloji erzincan, Turkey, 24610 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Universitesi Istanbul Tip Fakultesi Istanbul, Turkey, 34093 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Koc Universitesi Tip Fakultesi - Radyoloji Istanbul, Turkey, 34010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi Istanbul, Turkey, 34098 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ondokuz Mayis Uni Tip Fakultesi Samsun, Turkey, 55139 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University Multiprofile Hospital for Active Treatment Dr Georgi Stranski Pleven | Surgery Department Pleven, Bulgaria, 5800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsmed Göttingen Institut f. Diag&Interv Radiologie Göttingen, Germany, 37075 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Helios Herzzentrum Leipzig - Abteilung für Radiologie Leipzig, Germany, 04289 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniklinik Freiburg / Radiologie Freiburg, Germany, 79106 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniklinik Bonn / Radiologie Bonn, Germany, 53127 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Essen - Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie - 21197 Essen, Germany, 45147 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HELIOS Klinikum Berlin - Buch Berlin, Germany, 13125 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Debreceni Egyetem Klinikai Kozpont Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre Hospitalier Universitaire - Angers Angers, France, 49933 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospices Civils de LYON LYON, France, 69229 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Bichat - Paris PARIS, France, 75018 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Akademiska Sjukhuset Uppsala, Sweden, 751 85 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations London Health Sciences Centre (LHSC) - University Hospital London, Canada, N6A 5A5 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NZOZ Kendron Bialystok, Poland, 15-402 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hakodate Central General Hospital Hakodate, Japan, 040-8585 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inje University Busan Paik Hospital Busan, South Korea, 47392 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Biogenix Molecular, LLC Miami, United States, 33165 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Randomized
Blinding:
N/A
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Visualization parameter contrast Enhancement assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICRContrast Enhancement will be 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 imagingTimeframe: 1 day procedure
- Visualization parameter delineation assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICRDelineation will be 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 imagingTimeframe: 1 day procedure
- Visualization parameter morphology assessed by separate blinded evaluation of unenhanced and combined pre- and post-gadoquatrane MRI, by a BICRMorphology will be 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 imagingTimeframe: 1 day procedure
Secondary Outcome
- 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 BICRContrast Enhancement will be 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 agentsTimeframe: 1 day procedure
- 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 BICRDelineation will be 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 agentsTimeframe: 1 day procedure
- 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 BICRMorphology will be 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 agentsTimeframe: 1 day procedure
- 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 BICRBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsTimeframe: 1 day procedure
- 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 BICRBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsTimeframe: 1 day procedure
- The overall diagnostic clinical value of combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAsThe overall diagnostic clinical value is composed of 2 elements and 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 5-point scale (1- no diagnostic clinical value from contrast enhancement, 2- poor diagnostic clinical value from contrast enhancement, 3- moderate diagnostic clinical value from contrast enhancement, 4- good diagnostic clinical value from contrast enhancement, 5- excellent diagnostic clinical value from contrast enhancement), by the BICR and the Investigator; ii. the evaluation of patient management based on the diagnostic reporting recommendations (i.e., likely diagnosis), by the Investigator. BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imagingTimeframe: 1 day procedure
- 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 investigatorBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsTimeframe: 1 day procedure
- 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 investigatorBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsTimeframe: 1 day procedure
- Diagnoses from combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by the InvestigatorBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsTimeframe: 1 day procedure
- Confidence in diagnosis combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs by BICR and by InvestigatorThe degree of confidence will be rated on a 4-point scale: 1 = Not confident， 2 = Somewhat confident, 3 = Confident, 4 = Very confident. BICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsTimeframe: 1 day procedure
- Number of lesions seen on unenhanced MRI image set and combined pre- and post-gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICRBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsTimeframe: 1 day procedure
- Number of enhancing lesions seen on combined pre- and post- gadoquatrane MRI and combined pre- and post-comparator MRI with macrocyclic GBCAs, by a BICRBICR = blinded independent central read / blinded independent central readers; MRI = magnetic resonance imaging; GBCAs = gadolinium-based contrast agentsTimeframe: 1 day procedure
- 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 investigatorGBCAs = gadolinium-based contrast agentsTimeframe: 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 investigatorGBCAs = gadolinium-based contrast agentsTimeframe: Within 24 ± 4 hours after administration of gadoquatrane or any approved macrocyclic GBCAs
Additional Information
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