check_circleStudy Completed

Breast Cancer

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

Both

Age

18 Years
  • - 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:
     -- a. patient is younger than 50 years;
     -- b. patient has heterogeneously or extremely dense breasts;
     -- c. 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.
  • - 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

Trial summary

Enrollment Goal
460
Trial Dates
May 2010 - January 2012
Phase
Phase 3
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 reader
    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 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 injection
    enhanced_encryption
    Safety Issue:
    No
  • Difference of 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 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 injection
    enhanced_encryption
    Safety Issue:
    No
  • 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 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 injection
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Breast level specificity of CMRM based on malignant breasts
    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).
    date_rangeTime Frame:
    Immediately before injection and after injection
    enhanced_encryption
    Safety Issue:
    No
  • Percentage difference of participants whose index cancers were detected using CMRM vs UMRM, CMRM vs XRM, and CMRM vs CMRM+XRM
    Index 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 injection
    enhanced_encryption
    Safety Issue:
    No
  • Percentage difference of participants whose additional index 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
    date_rangeTime Frame:
    Immediately before injection and after injection
    enhanced_encryption
    Safety Issue:
    No
  • 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 level
    The 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 injection
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1