Trial Condition(s):
Renal artery obstruction
Gadobutrol enhanced MRA of the renal arteries (GRAMS)
Bayer Identifier:
91759
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required.
This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study.
MRA and CTA images will be collected for an independent review (blinded read).
Inclusion Criteria
- Male or female subjects, aged ≥ 18 years - Known or suspected renal artery disease based on any of the following: -- Referred for evaluation of the renal arteries for clinically significant stenosis -- Follow-up for a metallic stent in a renal artery -- Prior imaging study (CTA) showing ≥ 50% renal artery stenosis (within 60 days prior to consent) - Willingness to undergo the routine Contrast Enhanced Magnetic Resonance Angiography (CE MRA) examinations with gadobutrol. - Willingness and ability to follow directions and complete all study procedures specified in the protocol. - Females of childbearing potential only: Negative pregnancy test on the day of the MRA prior to administration of study drug. - Written informed consent (IC), including information about the provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable.
Exclusion Criteria
- Pregnant or nursing (including pumping for storage and feeding) - Received any other investigational product or participation in any other clinical trial within 30 days before enrollment into this study - Previous enrolment into this study or into any other Bayer sponsored study using gadobutrol - Contraindication to the MRA examinations (e.g. inability to hold breath; severe arrhythmias; very low cardiac output, severe claustrophobia, defibrillators or other metallic devices not approved for MRI) - Contraindication to the use of Gd-containing contrast agents (including subjects with suspicion for or known to have Nefrogenic Systemic Fibrosis (NSF) - History of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents - Received any contrast agent within 72 hours before the study MRA, or scheduled receipt of any contrast agent within 24 hours after the study MRA (Note: This applies also to a CTA potentially scheduled during the course of the study.) - Estimated glomerular filtration rate (eGFR) value < 30 ml/min/1.73 m2 derived from a serum creatinine result within 2 weeks before the gadobutrol injection. Any subject on hemodialysis or peritoneal dialysis is excluded from participation. Use the value obtained prior to and closest to the time of the MRA, if there are multiple creatinine values. (Do not use the core lab value if not available prior to the MRA.) - Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period - Severe cardiovascular disease (e.g. acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or known long QT syndrome
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 Inselspital Bern Bern, Switzerland, CH-3010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Zürich Zürich, Switzerland, 8091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kantonsspital Olten Olten, Switzerland, 4600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital das Clínicas da Faculdade de Medicina da USP Sao Paulo, Brazil, 05403-900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Friedrich-Schiller-Universität Jena Jena, Germany, 07740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städtisches Klinikum Karlsruhe gGmbH Karlsruhe, Germany, 76133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Schleswig-Holstein / AÖR Lübeck, Germany, 23538 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Christian-Albrechts-Universität Kiel, Germany, 24105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SouthCoast Imaging Center Savannah, United States, 31406 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northwestern University Feinberg School of Medicine Chicago, United States, 60611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Methodist Le Bonheur Healthcare Memphis, United States, 38104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Wisconsin - Madison Madison, United States, 53705 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Texas Health Science Center San Antonio, United States, 78229-3900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Duke University Medical Center Durham, United States, 27710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rhode Island Hospital Providence, United States, 02903-4900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johns Hopkins University Baltimore, United States, 21287 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UCLA Medical Center Los Angeles, United States, 90095 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Miami School of Medicine Miami, United States, 33136 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Europeen Georges Pompidou Paris, France, 75908 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CH Pitie Salpetiere, Service de Radiologie Centrale 47-83 Paris Cedex 13, France, 75651 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Bichat - Paris PARIS, France, 75877 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire Brabois VANDOEUVRE-LES-NANCY, France, 54500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center Hospitalier Michallon - Grenoble LA TRONCHE, France, 38700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Charles Nicolle - Rouen Cedex ROUEN CEDEX, France, 76031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital im. N. Barlickiego Lodz, Poland, 90-153 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samodzielny Publiczny Szpital Kliniczny nr 4 Lublin, Poland, 20-090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Medyczne Warszawskiego Uniwersytetu Medycznego Warszawa, Poland, 02-097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nemocnice na Homolce Praha 5, Czech Republic, 150 30 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vseobecna fakultni nemocnice Praha 2, Czech Republic, 12808 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni Nemocnice Olomouc Olomouc, Czech Republic, 775 20 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Plzen Plzen, Czech Republic, 304 60 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Brno Brno, Czech Republic, 625 00 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Diagnóstico por Imágenes Adrogué Adrogué, Argentina, B1846DWA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro de Diagnóstico Dr. Enrique Rossi Buenos Aires, Argentina, C1425BEE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Diagnóstico Médico Oroño Rosario, Argentina, S2000DTC | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Innsbruck Innsbruck, Austria, 6020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Doz. Dr. Stiglbauer & Partner Wiener Neustadt, Austria, 2700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gazi Univ. Medical Faculty Ankara, Turkey, 06500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Istanbul Universitesi Cerrahpasa Tip Fakultesi Istanbul, Turkey, 34098 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Istanbul Univ. Medical Faculty Istanbul, Turkey | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Baskent University Medical Faculty Istanbul, Turkey | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UNIFESP/EPM Sao Paulo, Brazil, 04023-061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Israelita Albert Einstein São Paulo, Brazil, 05651-901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Moinhos de Vento-Centro Clínico Porto Alegre, Brazil, 90035-001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital das Clínicas da Faculdade de Medicina da USP Sao Paulo, Brazil, 05403-000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations L'Dor - Instituto de Ensino e Pesquisa Rio de Janeiro, Brazil, 22281-100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul Asan Medical Center Seoul, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ajou University Hospital Suwon, South Korea, 443-721 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gangnam Severance Hospital, Yonsei University Seoul, South Korea, 135-720 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsspital Basel Basel, Switzerland, 4031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shing-Kong Wu Ho-Su Memorial Hospital Taipei, Taiwan, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Veterans General Hospital Taipei, Taiwan, China, 11217 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chang Gung Memorial Hospital at Linkou Taoyuan, Taiwan, China, 333 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wan Fang Hospital Taipei, Taiwan, China, 116 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Specjalistyczny im. Jana Pawla II Krakow, Poland, 31-02 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Santa Fe de Bogotá - Hospital Universitario Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Instituto de Alta tecnología médica de Antioquia Medellín, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations DIME Clinica Neurocardiovascular S.A. Cali, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CENTRO DE DIAGNOSTICO MEDICO Medellín, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Florida College of Medicine Jacksonville, United States, 32209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Radiology Ltd. Tucson, United States, 85711 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aurora Saint Luke's Medical Center Milwaukee, United States, 53215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UC Irvine Medical Center Orange, United States, 92660 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Southern California Los Angeles, United States, 90033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vivantes Klinikum Neukölln Berlin, Germany, 12351 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Franziskus-Hospital GmbH Münster, Germany, 48145 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica de la Costa LTDA Barranquilla, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Veterans General Hospital Kaoshiung, Taiwan, China, 81346 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Multicenter, open-label study to evaluate the safety and efficacy (by blinded reading) of Gadobutrol-enhanced magnetic resonance angiography (MRA) after a single injection of 0.1 mmol/kg of Gadobutrol in subjects with known or suspected renal artery disease
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Fraction of assessable segmentsTimeframe: At approximately 15 months after last patient last visit.
- Sensitivity for detection of clinically significant disease (50 to 99% stenosis) on a segmental basisTimeframe: At approximately 15 months after last patient last visit.
- Specificity for exclusion of clinically significant disease (50 to 99% stenosis) on a segmental basisTimeframe: At approximately 15 months after last patient last visit.
- Gadovist minimum performance criteria: Sensitivity > 50%Timeframe: At approximately 15 months after last patient last visit.
- Gadovist minimum performance criteria: Specificity > 50%Timeframe: At approximately 15 months after last patient last visit.
Secondary Outcome
- Minimum diameter of the segmentTimeframe: At approximately 15 months after last patient last visit.
- Location and length of stenotic segments with ≥ 50% stenosisTimeframe: At approximately 15 months after last patient last visit.
- Aneurysmal dilatationTimeframe: At approximately 15 months after last patient last visit.
- Artifacts by type (segmental)Timeframe: At approximately 15 months after last patient last visit.
- Diagnostic confidence (segmental)Timeframe: At approximately 15 months after last patient last visit.
- Additional imaging studies recommended (example: non contrast MRA, contrast enhanced MRA, computed tomography angiography, Ultrasound, Nuclear medicine study)What additional imaging studies would be necessary is a measure of 1) what test provides a definitive diagnosis for treatment decisions and 2) is a direct measure of additional cost a health system would incur for additional imaging studies to reach a definitive diagnosis. This is critical to determining the total cost of imaging for a patient diagnosis in any health system reimbursement structure. Therefore the social/societal cost for not providing a definitive diagnosis with a single imaging study can be determined for health policy and reimbursement decisions.Timeframe: At approximately 15 months after last patient last visit.
Additional Information
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