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Sponsor determined there was sufficient material collected to answer the study questions.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CE-BMRI | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CE-BMRI | Device | Contrast-enhanced breast imaging using Magnetic Resonance |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of CE-BMRI and DE-CEDM | Subjects have completed both CE-BMRI and DE-CEDM scan types | Approximately 8 weeks |
| Average Maximum Lesion Size by CE-BMRI Scan | Average maximum lesion size when scanned using CE-BMRI | Within 1 week of CE-BMRI scan |
| Average Maximum Lesion Size by DE-CEDM | Average maximum lesion size when scanned using DE-CEDM | Within 1 week of DE-CEDM scan |
| Average Maximum Lesion Size by Histology Outcome | Average maximum lesion size as described in histology report. | Approximately 1 week; upon completion of 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. | This outcome did not occur due to premature study stop. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States | ||
| AZ St-Jan Brugge AV |
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Women 21 years of age or older, with newly diagnosed cancer identified through through core biopsy or fine-needle aspiration (FNA) within the last 30 days and with a bilateral CE-BMRI performed within 30 days of the new breast cancer diagnosis.
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| ID | Title | Description |
|---|---|---|
| FG000 | CE-BMRI and DE-CEDM Examinations | 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. CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants enrolled in study.
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| ID | Title | Description |
|---|---|---|
| BG000 | CE-BMRI and DE-CEDM Examinations | 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. CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Completion of CE-BMRI and DE-CEDM | Subjects have completed both CE-BMRI and DE-CEDM scan types | Total number of participants enrolled in the study | Posted | Count of Participants | Participants | Approximately 8 weeks |
|
|
Duration of scan - approximately 1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CE-BMRI and DE-CEDM Examinations | 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. CE-BMRI: Contrast-enhanced breast imaging using Magnetic Resonance DE-CEDM: Breast imaging using Dual-energy, contrast-enhanced digital mammography |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Paul Antonini | GE Healthcare | +33 130709703 | Jean-Paul.antonini@ge.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| DE-CEDM |
| Device |
Breast imaging using Dual-energy, contrast-enhanced digital mammography |
|
| Bruges |
| Belgium |
| Sunnybrook Health Science Centre | Toronto | Canada |
| Institut Goustave Roussy | Villejuif | France |
| Institut fur Radiologie, Charite | Berlin | Germany |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Average Maximum Lesion Size by CE-BMRI Scan | Average maximum lesion size when scanned using CE-BMRI | All subjects who completed both CE-BMRI and DE-CEDM examinations | Posted | Mean | Full Range | millimeters (mm) | Within 1 week of CE-BMRI scan |
|
|
|
| Primary | Average Maximum Lesion Size by DE-CEDM | Average maximum lesion size when scanned using DE-CEDM | All subjects who completed both CE-BMRI and DE-CEDM examinations | Posted | Mean | Full Range | millimeters (mm) | Within 1 week of DE-CEDM scan |
|
|
|
| Primary | Average Maximum Lesion Size by Histology Outcome | Average maximum lesion size as described in histology report. | Subjects who underwent CE-BMRI and DE-CEDM | Posted | Mean | Full Range | millimeters (mm) | Approximately 1 week; upon completion of histology report |
|
|
|
| Primary | 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. | Study was prematurely stopped. | Posted | This outcome did not occur due to premature study stop. |
|
|
| 0 |
| 224 |
| 0 |
| 224 |
| 9 |
| 224 |
| extravasation | General disorders | Non-systematic Assessment |
|
| Allergy to contrast media | Immune system disorders | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |