Gadobutrol Magnevist-controlled Body Study
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01050829
First received: January 13, 2010
Last updated: April 14, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Magnetic Resonance Imaging |
Drug: Gadobutrol (Gadovist, BAY86-4875) Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Diagnostic |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology. [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Sensitivity and specificity for the detection of malignant lesions [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
- Exact match of the MR diagnosis with the final clinical diagnosis based on medical records up until 3 months after the scan [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
- Confidence in diagnosis [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
| Enrollment: | 371 |
| Study Start Date: | January 2010 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Gadobutrol (Gadovist, BAY86-4875)
Single administration at a dose of 0.1 mmol/kg
|
| Active Comparator: Arm 2 |
Drug: Gadopentetate Dimeglumine (Magnevist, BAY86-4882)
Single administration at a dose of 0.1 mmol/kg
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050829
Locations
| China, Jiangsu | |
| Nanjing, Jiangsu, China, 210009 | |
| Suzhou, Jiangsu, China, 215006 | |
| China, Shanxi | |
| Xi'an, Shanxi, China, 710032 | |
| China | |
| Beijing, China, 100853 | |
| Shanghai, China, 200032 | |
| Shanghai, China, 200233 | |
| Japan | |
| Kamogawa, Chiba, Japan, 296-0041 | |
| Matsuyama, Ehime, Japan, 791-0280 | |
| Chikushino, Fukuoka, Japan, 818-8516 | |
| Kobe, Hyogo, Japan, 650-0047 | |
| Sunto, Shizuoka, Japan, 411-8777 | |
| Bunkyo-ku, Tokyo, Japan, 113-8431 | |
| Fukuoka, Japan, 812-0033 | |
| Korea, Republic of | |
| Seoul, Korea, Republic of, 158-710 | |
| Seoul, Korea, Republic of, 150-713 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01050829 History of Changes |
| Other Study ID Numbers: | 13297 |
| Study First Received: | January 13, 2010 |
| Last Updated: | April 14, 2013 |
| Health Authority: | China: Food and Drug Administration Japan: Pharmaceuticals and Medical Devices Agency Republic of Korea: Korean Food and Drug Administration |
Keywords provided by Bayer:
|
Magnetic resonance imaging Tumor Contrast media Gadobutrol |
ClinicalTrials.gov processed this record on May 16, 2013