Breast Cancer
Conditions
Keywords
mammography
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.
Interventions
DEVICECE-BMRI
Contrast-enhanced breast imaging using Magnetic Resonance
DEVICEDE-CEDM
Breast imaging using Dual-energy, contrast-enhanced digital mammography
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of CE-BMRI and DE-CEDM | Approximately 8 weeks | Subjects have completed both CE-BMRI and DE-CEDM scan types |
| Average Maximum Lesion Size by CE-BMRI Scan | Within 1 week of CE-BMRI scan | Average maximum lesion size when scanned using CE-BMRI |
| Average Maximum Lesion Size by DE-CEDM | Within 1 week of DE-CEDM scan | Average maximum lesion size when scanned using DE-CEDM |
| Average Maximum Lesion Size by Histology Outcome | Approximately 1 week; upon completion of histology report | Average maximum lesion size as described in histology report. |
| Multi-reader Evaluation of Images | This outcome did not occur due to premature study stop. | 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. |
Countries
Belgium, Canada, France, Germany, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 224 |
| Total | 224 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not complete both imaging methods | 5 |
| Overall Study | Did not meet all I/E after screening | 31 |
| Overall Study | Discontinuation of study | 60 |
Baseline characteristics
| Characteristic | CE-BMRI and DE-CEDM Examinations |
|---|---|
| Age, Customized Subjects age 21 years or older | 224 Participants |
| Region of Enrollment Belgium | 29 participants |
| Region of Enrollment Canada | 5 participants |
| Region of Enrollment France | 59 participants |
| Region of Enrollment Germany | 118 participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 224 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 224 |
| other Total, other adverse events | 9 / 224 |
| serious Total, serious adverse events | 0 / 224 |
Outcome results
Primary
Average Maximum Lesion Size by CE-BMRI Scan
Average maximum lesion size when scanned using CE-BMRI
Time frame: Within 1 week of CE-BMRI scan
Population: All subjects who completed both CE-BMRI and DE-CEDM examinations
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CE-BMRI and DE-CEDM Examinations | Average Maximum Lesion Size by CE-BMRI Scan | 28.8 millimeters (mm) |
Primary
Average Maximum Lesion Size by DE-CEDM
Average maximum lesion size when scanned using DE-CEDM
Time frame: Within 1 week of DE-CEDM scan
Population: All subjects who completed both CE-BMRI and DE-CEDM examinations
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CE-BMRI and DE-CEDM Examinations | Average Maximum Lesion Size by DE-CEDM | 30.5 millimeters (mm) |
Primary
Average Maximum Lesion Size by Histology Outcome
Average maximum lesion size as described in histology report.
Time frame: Approximately 1 week; upon completion of histology report
Population: Subjects who underwent CE-BMRI and DE-CEDM
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CE-BMRI and DE-CEDM Examinations | Average Maximum Lesion Size by Histology Outcome | 28.2 millimeters (mm) |
Primary
Completion of CE-BMRI and DE-CEDM
Subjects have completed both CE-BMRI and DE-CEDM scan types
Time frame: Approximately 8 weeks
Population: Total number of participants enrolled in the study
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CE-BMRI and DE-CEDM Examinations | Completion of CE-BMRI and DE-CEDM | Subjects completing both scan types | 128 Participants |
| CE-BMRI and DE-CEDM Examinations | Completion of CE-BMRI and DE-CEDM | Subjects did not complete both scan typess | 96 Participants |
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.
Time frame: This outcome did not occur due to premature study stop.
Population: Study was prematurely stopped.