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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- GE Healthcare
- Enrollment
- 224
- Locations
- 5
- Primary Endpoint
- Average Maximum Lesion Size by Histology Outcome
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
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).
Outcomes
Primary Outcomes
Average Maximum Lesion Size by Histology Outcome
Time Frame: Approximately 1 week; upon completion of histology report
Average maximum lesion size as described in histology report.
Completion of CE-BMRI and DE-CEDM
Time Frame: Approximately 8 weeks
Subjects have completed both CE-BMRI and DE-CEDM scan types
Average Maximum Lesion Size by CE-BMRI Scan
Time Frame: Within 1 week of CE-BMRI scan
Average maximum lesion size when scanned using CE-BMRI
Average Maximum Lesion Size by DE-CEDM
Time Frame: Within 1 week of DE-CEDM scan
Average maximum lesion size when scanned using DE-CEDM
Multi-reader Evaluation of Images
Time Frame: 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.