Back to resultsEfficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI
Primary Purpose
Breast Cancer, Diagnostic Imaging
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Gadobutrol-enhanced MRI, Mammography
Eligibility Criteria
Inclusion Criteria:
- Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.
If female, a digital XRM is required if any of the following criteria is met:
- patient is younger than 50 years;
- patient has heterogeneously or extremely dense breasts;
- is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
- If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
- Has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.
Exclusion Criteria:
- Is a female patient who is pregnant or lactating
- Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
- Has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
- Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).
- Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m^2).
- Has received chemotherapy or hormonal therapy for breast cancer within 6 months.
- Has received hormone replacement therapy within 4 weeks prior to study drug administration.
- Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
- Has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gadobutrol (Gadavist, BAY86-4875)
Arm Description
Patients first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an intravenous injection (i.v.) injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
Outcomes
Primary Outcome Measures
Difference for Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader
For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. 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).
Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader
For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.
Breast Level Specificity of CMRM for Non-malignant Breasts by Reader
A 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 specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.
Secondary Outcome Measures
Breast Level Specificity of CMRM Based on Malignant Breasts
A malignant breast was defined as false positive (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 true negative (TN). Specificity was then defined as TN/(TN+FP).
Percentage Difference of Participants Whose Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM
Index cancer is defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.
Percentage Difference of Participants Whose Additional Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM
Additional 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 study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01067976
Brief Title
Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI
Official Title
An Open Label, Multi-center, Phase 3 Study With Corresponding Blinded Image Reading to Determine the Efficacy and Safety of a Single Intravenous Injection of 0.1 mmol/kg Body Weight of Gadobutrol 1.0 Molar (Gadovist®) in Patients With Newly Diagnosed Breast Cancer Referred for Contrast-enhanced Breast MRI
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Diagnostic Imaging
Keywords
Breast Cancer, Gadobutrol-enhanced MRI, Mammography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
446 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gadobutrol (Gadavist, BAY86-4875)
Arm Type
Experimental
Arm Description
Patients first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an intravenous injection (i.v.) injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
Intervention Type
Drug
Intervention Name(s)
Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Intervention Description
A single bolus injection of gadobutrol 1.0 M 0.1mmol/kg body weight
Primary Outcome Measure Information:
Title
Difference for Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader
Description
For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The difference was calculated as CMRM value minus UMRM value. 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).
Time Frame
Immediately before injection and after injection
Title
Sensitivity for Detection of Full Extent of Malignant Breast Disease Using CMRM vs UMRM Per Reader
Description
For a single participant the sensitivity was defined as the proportion of malignant breast regions that were recognized by the clinical investigators and the 3 blinded readers using the respective imaging modality as malignant. Subsequently the sensitivity percentage was calculated based on the mean of the sensitivities across all participants.
Time Frame
Immediately before injection and after injection
Title
Breast Level Specificity of CMRM for Non-malignant Breasts by Reader
Description
A 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 specificity percentage was calculated based on the mean of the specificities across all participants who contributed with at least one non-malignant breast.
Time Frame
Immediately before injection and after injection
Secondary Outcome Measure Information:
Title
Breast Level Specificity of CMRM Based on Malignant Breasts
Description
A malignant breast was defined as false positive (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 true negative (TN). Specificity was then defined as TN/(TN+FP).
Time Frame
Immediately before injection and after injection
Title
Percentage Difference of Participants Whose Index Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM
Description
Index cancer is defined as the cancer confirmed by histology prior to inclusion which made the participants eligible for the study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.
Time Frame
Immediately before injection and after injection
Title
Percentage Difference of Participants Whose Additional Cancers Were Detected Using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM
Description
Additional 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 study. The difference in percentage of participants was calculated as CMRM value minus UMRM value, CMRM value minus XRM value, CMRM value minus CMRM+XRM value respectively.
Time Frame
Immediately before injection and after injection
Other Pre-specified Outcome Measures:
Title
Breast Level Specificity for All Breasts by Imaging Modality and by Reader
Description
A non-malignant breast was defined as FP when the reader assessed at least one breast region as malignant. A 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 (N-FP)/N, where N was total number of breasts.
Time Frame
Immediately before injection and after injection
Title
Categorical Accuracy Difference of Extent of Malignant Disease Verified by SoT by Majority Reader, Breast Region Level
Description
For each region the reader chose the category which best described the extent of malignant disease, i.e. no, unifocal, or multifocal malignant breast disease. The proportion of correct matches of each defined image set to the SoT for the extent of malignant breast disease was referred to as the categorical accuracy. The majority read value for the 3 blinded readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.
Time Frame
Immediately before injection and after injection
Title
Categorical Accuracy Difference of Extent of Malignant Disease Verified by Histopathology by Majority Reader, Breast Region Level
Description
For each region the reader chose the category which best described the extent of malignant disease, i.e. no, unifocal, or multifocal malignant breast disease. The proportion of correct matches of each defined image set to the SoT for the extent of malignant breast disease was referred to as the categorical accuracy. The majority read value for the 3 blinded readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.
Time Frame
Immediately before injection and after injection
Title
Sensitivity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level
Description
For 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 sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.
Time Frame
Immediately before injection and after injection
Title
Sensitivity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level
Description
For 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 sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.
Time Frame
Immediately before injection and after injection
Title
Sensitivity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level
Description
For 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 sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.
Time Frame
Immediately before injection and after injection
Title
Specificity Difference in the Determination of Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level
Description
A 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). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.
Time Frame
Immediately before injection and after injection
Title
Specificity Difference in the Determination of Unifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level
Description
A 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). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.
Time Frame
Immediately before injection and after injection
Title
Specificity Difference in the Determination of Multifocal Malignant Breast Disease Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM, and CMRM+XRM vs XRM Verified by SoT, Breast Region Level
Description
A 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). The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for specificity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.
Time Frame
Single examination
Title
Sensitivity Difference of Detection of Multicentric Malignant Disease Verified by SoT by Majority Reader, Breast Level
Description
For 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 sensitivity percentage was calculated based on the mean of the sensitivities across all participants. The majority read value for the 3 blinded readers was determined at the disease state level (evaluable regions for sensitivity). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave a different categorical determination, the majority response was the most severe disease category given by any of the 3 readers. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.
Time Frame
Immediately before injection and after injection
Title
Accuracy Difference of Presence of Bilateral Malignant Disease Verified by SoT by Majority Reader, Participant Level
Description
The disease state "bilateral malignant disease" was derived from the assessment of the different regions for each breast (right and left) for investigators for each imaging modality (UMRM, CMRM, XRM, UMRM+XRM, and CMRM+XRM) based on the following rule: If the participant had at least one breast with no malignant region, the assessment of bilateral malignant disease was categorized as "No". If the participant had at least one malignant lesion in both breasts, the assessment of bilateral malignant disease was categorized as "Yes". The proportion of correct matches of each different image set to the SoT for the existence of bilateral malignant disease was derived. The analysis was based on the difference in accuracy for the evaluation of bilateral malignant disease for the following image comparisons on a participant level. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.
Time Frame
Immediately before injection and after injection
Title
Difference of Confidence in Diagnosis for Breast Region Diagnosis Using CMRM vs UMRM, CMRM+XRM vs UMRM+XRM and CMRM+XRM vs XRM by Majority Reader, Participant Level
Description
The 3 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). The majority read value for the 3 readers was determined at the disease state level (no disease, unifocal, multifocal). If 2 of 3 or all 3 readers gave the same categorical determination of malignant disease for a breast region, the majority reader response was that category. If all 3 readers gave different categorical determination, the majority reader response was the most severe disease category given by any of the 3 readers, i.e. multifocal. For each participant, the mean of the confidence responses for the diagnosed breast regions was calculated, and rounded to the nearest 0.5. value respectively. The difference was calculated as CMRM value minus UMRM value, CMRM+XRM value minus UMRM+XRM value, CMRM+XRM value minus XRM value respectively.
Time Frame
Immediately before injection and after injection
Title
Blinded Readers: Inter-reader Agreement on Categorical Accuracy Based on Assessment for UMRM vs CMRM - Breast Region Level
Description
Inter-reader agreement was assessed by considering each breast region to have 2 possibilities (malignant disease / no malignant disease) for an assessment by the 2 image sets (UMRM and CMRM). Kappa value varies from 0 (no agreement) to 1 (perfect agreement).
Time Frame
Immediately before injection and after injection
Title
Blinded Reader 1: Intra-reader Variability Based on Assessment for CMRM - Breast Level
Description
Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).
Time Frame
Immediately before injection and after injection
Title
Blinded Reader 2: Intra-reader Variability Based on Assessment for CMRM - Breast Level
Description
Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).
Time Frame
Immediately before injection and after injection
Title
Blinded Reader 3: Intra-reader Variability Based on Assessment for CMRM - Breast Level
Description
Intra-reader variability was assessed using a kappa on the match to SoT for the different regions within each participant (match, no match SoT). For each of the 3 readers, intra-reader agreement was assessed by considering each breast region to have 2 possibilities for an assessment by CMRM: matched SoT or did not match SoT. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).
Time Frame
Immediately before injection and after injection
Title
Vital Signs Change From Baseline and Follow-up 24 Hours Post Injection - Systolic and Diastolic Blood Pressure
Description
Systolic and diastolic blood pressure were measured in a supine position. Blood pressure was not to be measured on the arm used for the injection.
Time Frame
Baseline, Follow-up visit (24 hours post injection)
Title
Vital Signs Change From Baseline and Follow-up 24 Hours Post Injection - Heart Rate
Description
Heart rate was measured in a supine position.
Time Frame
Baseline, Follow-up visit (24 hours post injection)
Title
Number of Participants With at Least One Laboratory Parameter Change From Low or Normal at Baseline to Abnormally High at Follow-up 24 Hours Post Injection
Description
Number of participants with at least one occurrence of changing from low or normal at baseline to high at follow-up.
Time Frame
Baseline, Follow-up visit (24 hours post injection)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recent histologically proven diagnosis of breast cancer after having obtained X-Ray Mammography (XRM) of both breasts (according to American College of Radiology [ACR] and performed no longer than 6 weeks prior to enrollment into the study) and has been referred for a contrast-enhanced Magnetic Resonance Mammography (MRM) prior to surgery of the breast.
If female, a digital XRM is required if any of the following criteria is met:
patient is younger than 50 years;
patient has heterogeneously or extremely dense breasts;
is not post-menopausal (post-menopause defined as at least 12 months prior to inclusion without menstruation).
If female of childbearing potential, MRM should be performed on the 7-14th day of the menstrual cycle.
Has an estimated glomerular filtration rate (eGFR) value >/= 60 mL/min/1.73m^2 derived from a serum creatinine result within 2 weeks prior to study enrollment.
Exclusion Criteria:
Is a female patient who is pregnant or lactating
Has any contraindication to the MRM examination (e.g. metal implants, phobia) or the use of gadolinium-containing contrast agents.
Has received any contrast agent within 24 hours prior to the study MRM, or is scheduled to receive any contrast agent within 24 hours after the study MRM.
Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).
Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renal insufficiency (glomerular filtration rate < 60 mL/min/1.73m^2).
Has received chemotherapy or hormonal therapy for breast cancer within 6 months.
Has received hormone replacement therapy within 4 weeks prior to study drug administration.
Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
Has prior excisional biopsy or breast surgery less than 6 months before enrollment and between XRM and study MRM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658-6100
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007-2197
Country
United States
City
Springfield II
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1082A
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
City
Buenos Aires
State/Province
Ciudad Auton. de Buenos Aires
ZIP/Postal Code
C1425BEE
Country
Argentina
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05651-901
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
22649
Country
Brazil
City
Sao Paulo
Country
Brazil
City
Medellin
State/Province
Antioquia
Country
Colombia
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
City
Barranquilla
Country
Colombia
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
City
Tampere
ZIP/Postal Code
33521
Country
Finland
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35033
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
City
Bielefeld
State/Province
Nordrhein-Westfalen
Country
Germany
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44263
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45257
Country
Germany
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Milano
ZIP/Postal Code
20141
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Udine
ZIP/Postal Code
33100
Country
Italy
City
Ansan Si, Kyungki Do
ZIP/Postal Code
425-021
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
City
Chur
State/Province
Graubünden
ZIP/Postal Code
7000
Country
Switzerland
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
35462754
Citation
Endrikat J, Schmidt G, Haverstock D, Weber O, Trnkova ZJ, Barkhausen J. Sensitivity of Contrast-Enhanced Breast MRI vs X-ray Mammography Based on Cancer Histology, Tumor Grading, Receptor Status, and Molecular Subtype: A Supplemental Analysis of 2 Large Phase III Studies. Breast Cancer (Auckl). 2022 Apr 19;16:11782234221092155. doi: 10.1177/11782234221092155. eCollection 2022.
Results Reference
derived
PubMed Identifier
26840494
Citation
Sardanelli F, Newstead GM, Putz B, Jirakova Trnkova Z, Trimboli RM, Abe H, Haverstock D, Rosenberg M. Gadobutrol-Enhanced Magnetic Resonance Imaging of the Breast in the Preoperative Setting: Results of 2 Prospective International Multicenter Phase III Studies. Invest Radiol. 2016 Jul;51(7):454-61. doi: 10.1097/RLI.0000000000000254.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu
Description
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Learn more about this trial
Efficacy and Safety of Gadobutrol 1.0 Molar (Gadovist) for Breast MRI
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