check_circleStudy Completed
Magnetic Resonance Imaging
Bayer Identifier:
13297
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Gadobutrol Magnevist-controlled Body Study
Trial 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.
Key Participants Requirements
Sex
BothAge
20 YearsTrial summary
Enrollment Goal
370Trial Dates
January 2010 - April 2011Phase
Phase 3Could I Receive a placebo
NoProducts
Gadavist/Gadovist (Gadobutrol, BAY86-4875)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kameda Clinic | Kamogawa, 296-0041, Japan |
Completed | Juntendo University Juntendo Hospital | Bunkyo-ku, 113-8431, Japan |
Completed | Institute of Biomedical Research and Innovation | Kobe, 650-0047, Japan |
Completed | Shikoku Cancer Center | Matsuyama, 791-0280, Japan |
Completed | Harasanshin Hospital | Fukuoka, 812-0033, Japan |
Completed | 1st Affiliated Hosp., 4th Military Med Univ. | Xi'an, 710032, China |
Completed | The 6th People's Hospital of Shanghai Jiao Tong University | Shanghai, 200233, China |
Completed | St. Mary Hospital | Seoul, 150-713, Korea, Republic Of |
Completed | Shizuoka Cancer Center | Sunto, 411-8777, Japan |
Completed | Saiseikai Futsukaichi Hospital | Chikushino, 818-8516, Japan |
Completed | Chinese PLA General Hosp. | Beijing, 100853, China |
Completed | Zhongshan Hospital Fudan University. | Shanghai, 200032, China |
Completed | Tumor Hospital, Fudan University | Shanghai, 200032, China |
Completed | 1st Affiliated hospital of Soochow University | Suzhou, 215006, China |
Completed | Zhongda Hosp. affiliated of Southeast Univ. | Nanjing, 210009, China |
Completed | Ewha Womans University Hospital | Seoul, 158-710, Korea, Republic Of |
Completed | Institute of Biomedical Research and Innovation | Kobe, 650-0047, Japan |
Primary Outcome
- The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology.date_rangeTime Frame:At Day 0enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Sensitivity and specificity for the detection of malignant lesionsdate_rangeTime Frame:At Day 0enhanced_encryptionnoSafety Issue:
- Exact match of the MR diagnosis with the final clinical diagnosis based on medical records up until 3 months after the scandate_rangeTime Frame:At Day 0enhanced_encryptionnoSafety Issue:
- Confidence in diagnosisdate_rangeTime Frame:At Day 0enhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
RandomizedBlinding
Single BlindAssignment
Parallel AssignmentTrial Arms
2