Back to resultsContrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CE-BMRI
DE-CEDM
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring mammography
Eligibility Criteria
Inclusion Criteria:
- Woman 21 years of age or older
- The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained.
- Newly diagnosed with Breast Cancer (DCIS or invasive) identified through core biopsy or fine-needle aspiration (FNA) within last 30 days.
- Will have or have had a bilateral CE-BMRI performed within 30 days AFTER the new breast cancer diagnosis.
Exclusion Criteria:
- Woman who has already had a lumpectomy for the index lesion.
- Woman undergoing neoadjuvant chemotherapy treatment, hormone treatment or radiation therapy.
- Woman who is pregnant or who believe she may be pregnant.
- Woman who has breast implant.
- Woman who has a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (e.g., allergy to either agent or severely impaired renal function).
Sites / Locations
- Seattle Cancer Care Alliance
- AZ St-Jan Brugge AV
- Sunnybrook Health Science Centre
- Institut Goustave Roussy
- Institut fur Radiologie, Charite
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CE-BMRI
Arm Description
Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.
Outcomes
Primary Outcome Measures
Completion of CE-BMRI and DE-CEDM
Subjects have completed both CE-BMRI and DE-CEDM scan types
Average Maximum Lesion Size by CE-BMRI Scan
Average maximum lesion size when scanned using CE-BMRI
Average Maximum Lesion Size by DE-CEDM
Average maximum lesion size when scanned using DE-CEDM
Average Maximum Lesion Size by Histology Outcome
Average maximum lesion size as described in histology report.
Multi-reader Evaluation of Images
Multi-reader evaluation of images and comparison between CE-BMRI vs. DE-CEDM to determine which technology can more precisely measure cancer size as determined by pathological examination was planned. This was not conducted due to premature stop of the study.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01303419
Brief Title
Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer
Official Title
A Multicenter, Open-Label, Crossover Trial to Assess Non-Inferiority of Dual Energy Contrast-Enhanced Digital Mammography (DE-CEDM) Compared to Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) for Identifying a Change in Patient Management in Women With Newly Diagnosed Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor determined there was sufficient material collected to answer the study questions.
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 30, 2012 (Actual)
Study Completion Date
June 30, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM).
Detailed Description
Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM). Maximum lesion size was compared between the two imaging types. Subject data from both scans was planned to be included in a multi-reader evaluation; however, due to premature stop of the study, multi-reader data was not collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
mammography
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CE-BMRI
Arm Type
Experimental
Arm Description
Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.
Intervention Type
Device
Intervention Name(s)
CE-BMRI
Intervention Description
Contrast-enhanced breast imaging using Magnetic Resonance
Intervention Type
Device
Intervention Name(s)
DE-CEDM
Intervention Description
Breast imaging using Dual-energy, contrast-enhanced digital mammography
Primary Outcome Measure Information:
Title
Completion of CE-BMRI and DE-CEDM
Description
Subjects have completed both CE-BMRI and DE-CEDM scan types
Time Frame
Approximately 8 weeks
Title
Average Maximum Lesion Size by CE-BMRI Scan
Description
Average maximum lesion size when scanned using CE-BMRI
Time Frame
Within 1 week of CE-BMRI scan
Title
Average Maximum Lesion Size by DE-CEDM
Description
Average maximum lesion size when scanned using DE-CEDM
Time Frame
Within 1 week of DE-CEDM scan
Title
Average Maximum Lesion Size by Histology Outcome
Description
Average maximum lesion size as described in histology report.
Time Frame
Approximately 1 week; upon completion of histology report
Title
Multi-reader Evaluation of Images
Description
Multi-reader evaluation of images and comparison between CE-BMRI vs. DE-CEDM to determine which technology can more precisely measure cancer size as determined by pathological examination was planned. This was not conducted due to premature stop of the study.
Time Frame
This outcome did not occur due to premature study stop.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Woman 21 years of age or older
The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained.
Newly diagnosed with Breast Cancer (DCIS or invasive) identified through core biopsy or fine-needle aspiration (FNA) within last 30 days.
Will have or have had a bilateral CE-BMRI performed within 30 days AFTER the new breast cancer diagnosis.
Exclusion Criteria:
Woman who has already had a lumpectomy for the index lesion.
Woman undergoing neoadjuvant chemotherapy treatment, hormone treatment or radiation therapy.
Woman who is pregnant or who believe she may be pregnant.
Woman who has breast implant.
Woman who has a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (e.g., allergy to either agent or severely impaired renal function).
Facility Information:
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
AZ St-Jan Brugge AV
City
Brugge
Country
Belgium
Facility Name
Sunnybrook Health Science Centre
City
Toronto
Country
Canada
Facility Name
Institut Goustave Roussy
City
Villejuif
Country
France
Facility Name
Institut fur Radiologie, Charite
City
Berlin
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer
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