Trial Condition(s):
Gadobutrol Magnevist-controlled Body Study
13297
Not Available
Not Available
The purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the body/extremities regions. The results of the MRI with gadobutrol injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with Magnevist.
- Is at least 20 years of age - Is referred for a contrast-enhanced MRI of the body/extremities based on current clinical symptoms or results of a previous imaging procedure - Is willing to undergo the routine contrast-enhanced MRI examinations - Is willing and able to complete all study procedures specified in the protocol - Subject is male, or is female not of childbearing potential, or is female of childbearing potential who is using any medically accepted means of contraception and has a negative urine pregnancy test prior to the administration of gadobutrol or Magnevist
- Is a female subject who is pregnant or nursing - Has received any investigational product or has participated in any other clinical trial within 2 weeks prior to enrolling in this study - Has been previously enrolled in this study or any other study using gadobutrol - Has any contraindication to the MRI examinations or the use of Gd-containing contrast agents - Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents - Has received any contrast agent within 24 hours prior to the study MRI - Has a glomerular filtration rate value <30 mL/min/1.73m2 derived from a serum creatinine result within 4 weeks prior to study enrollment - Is considered clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure) - Has severe cardiovascular disease (eg, acute myocardial infarction (<14 days), unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (<48 hours) - Patients with acute renal insufficiency of any severity due to hepato-renal syndrome or in the perioperative liver transplantation period - Has any contraindication to Magnevist according to the package insert
Locations | |
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Locations Kameda Clinic Kamogawa, Japan, 296-0041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Juntendo University Juntendo Hospital Bunkyo-ku, Japan, 113-8431 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institute of Biomedical Research and Innovation Kobe, Japan, 650-0047 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shikoku Cancer Center Matsuyama, Japan, 791-0280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Harasanshin Hospital Fukuoka, Japan, 812-0033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Affiliated Hosp., 4th Military Med Univ. Xi'an, China, 710032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The 6th People's Hospital of Shanghai Jiao Tong University Shanghai, China, 200233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Mary Hospital Seoul, South Korea, 150-713 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shizuoka Cancer Center Sunto, Japan, 411-8777 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saiseikai Futsukaichi Hospital Chikushino, Japan, 818-8516 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chinese PLA General Hosp. Beijing, China, 100853 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zhongshan Hospital Fudan University. Shanghai, China, 200032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tumor Hospital, Fudan University Shanghai, China, 200032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Affiliated hospital of Soochow University Suzhou, China, 215006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zhongda Hosp. affiliated of Southeast Univ. Nanjing, China, 210009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ewha Womans University Hospital Seoul , South Korea, 158-710 | Contact Us: E-mail: [email protected] Phone: Not Available |
A Multi-center/multi-national, randomized, controlled, single-blind, group comparison Phase 3 study to determine the efficacy and safety of gadobutrol 1.0 molar in comparison to Magnevist following single injection in patients referred for contrast-enhanced MRI of the body/extremities regions (breast, heart, abdomen, kidney, pelvis, or extremities)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Randomized
Blinding:
Single Blind
Assignment:
Parallel Assignment
Trial Arms:
2