check_circleStudy Completed
Breast Cancer
Bayer Identifier:
91782
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Efficacy and safety of gadobutrol 1.0 molar (Gadovist) for breast magnetic resonance imaging (MRI)
Trial purpose
The purpose of this study is to look at the efficacy (how does it work) and safety of gadobutrol when used for obtaining MR images of both breasts.Women with a recent diagnosis of breast cancer by mammogram (X-ray examination of the breasts) may benefit from MRI of the breasts as MRI may detect additional breast cancers
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
460Trial Dates
May 2010 - January 2012Phase
Phase 3Could I Receive a placebo
NoProducts
Gadavist/Gadovist (Gadobutrol, BAY86-4875)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Greifswald, 17489, Germany | |
Withdrawn | Göttingen, 37081, Germany | |
Completed | München, 81377, Germany | |
Completed | Berlin, 10115, Germany | |
Completed | Frankfurt, 60596, Germany | |
Withdrawn | Münster, 48149, Germany | |
Completed | Columbus, 43212, United States | |
Completed | Tacoma, 98321, United States | |
Withdrawn | New York, 10065, United States | |
Completed | Gliwice, 44-100, Poland | |
Completed | Barcelona, 08036, Spain | |
Completed | Cordoba, 14004, Spain | |
Completed | Montreal, H4J 1C5, Canada | |
Completed | Erlangen, 91054, Germany | |
Withdrawn | Bochum, 44892, Germany | |
Completed | Chicago, 60637, United States | |
Completed | San Antonio, 78229, United States | |
Withdrawn | Providence, 02903, United States | |
Withdrawn | Warszawa, 02-781, Poland | |
Completed | Krakow, 30-501, Poland | |
Completed | Szczecin, 70-111, Poland | |
Completed | Sabadell, 08208, Spain | |
Completed | Alzira, Spain | |
Completed | Girona, 17002, Spain | |
Completed | Toronto, M5G 2M9, Canada | |
Withdrawn | Hamilton, L8N 4A6, Canada | |
Withdrawn | MAASTRICHT, 6229 HX, Netherlands | |
Completed | Buenos Aires, C1425BEE, Argentina | |
Completed | Buenos Aires, C1082A, Argentina | |
Completed | Delhi, 110085, India | |
Completed | Taipei, 100, Taiwan | |
Completed | Taipei, 114, Taiwan | |
Completed | Taipei, 110, Taiwan | |
Withdrawn | NIJMEGEN, 6525 GA, Netherlands | |
Withdrawn | Eindhoven, 5623, Netherlands | |
Completed | Buenos Aires, C1181ACH, Argentina | |
Completed | Mumbai, 400012, India | |
Completed | Mumbai, 400 004, India | |
Completed | Taichung, Taiwan | |
Completed | Taizung, 402, Taiwan | |
Completed | Oakland, 94609, United States | |
Completed | Tucson, 85724, United States | |
Completed | Englewood, 80112, United States | |
Completed | Toronto, M5S 1B2, Canada | |
Completed | Gera, 07548, Germany | |
Completed | Münster, 48145, Germany | |
Completed | Göttingen, 37075, Germany | |
Completed | Bydgoszcz, 85-796, Poland |
Primary Outcome
- Sensitivity for detection of full extent of malignant breast disease using CMRM vs UMRM per readerFor a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates will be calculated based on the mean of the sensitivities across all participants. For ease of expression, the following abbreviations will be used: Magnetic Resonance Mammography (MRM), Unenhanced MRM (UMRM), combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM), X-ray mammography (XRM)date_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
- Difference of sensitivity for detection of full extent of malignant breast disease using CMRM vs UMRM per readerFor a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the reader using the respective imaging modality as malignant. Subsequently the point estimates were calculated based on the mean of the sensitivities across all participants.date_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
- Breast level specificity of CMRM for non-malignant breasts by readerA non-malignant breast was defined as false positive (FP), when the reader assessed at least one breast region as malignant. When all breast regions were assessed as non-malignant, the breast was defined as true negative (TN). Breast level specificity was first defined in participant as number of TN-breasts in participant divided by number of non-malignant breasts in participant. Subsequently the point estimates were calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.date_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Breast level specificity of CMRM based on malignant breastsA malignant breast was defined as FP, when the reader using the respective imaging modality assessed more breast regions as malignant as were present according to SoT. Otherwise the breast was assessed as TN. Specificity was then defined as TN/(TN+FP).date_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
- Percentage difference of participants whose index cancers were detected using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRMIndex cancer was defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study.date_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
- Percentage difference of participants whose additional index cancers were detected using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRMAdditional cancer was defined as cancer which was present according to SoT, but which was not defined as index cancer, i.e. was not known when the participant was enrolled into the studydate_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
- Difference of confidence in diagnosis for breast region diagnosis using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM and CMRM+XRM vs XRM by reader, participant levelThe investigator and the blinded readers each recorded his/her confidence in diagnosis for each breast region based on a 4-point scale (1 = not confident, 2 = somewhat confident, 3 = confident, and 4 = very confident). For each participant, the mean of the confidence responses for the diagnosed breast regions was calculated, and rounded to the nearest 0.5.date_rangeTime Frame:Immediately before injection and after injectionenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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