Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer

Not Applicable

Terminated

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.

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
CE-BMRI	CE-BMRI	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	DE-CEDM	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.

Primary Outcome Measures

Name	Time	Method
Average Maximum Lesion Size by Histology Outcome	Approximately 1 week; upon completion of histology report	Average maximum lesion size as described in histology report.
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
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.

Secondary Outcome Measures

Name	Time	Method

Locations (5): AZ St-Jan Brugge AV
🇧🇪
Brugge, Belgium
Seattle Cancer Care Alliance
🇺🇸
Seattle, Washington, United States
Institut fur Radiologie, Charite
🇩🇪
Berlin, Germany
Sunnybrook Health Science Centre
🇨🇦
Toronto, Canada
Institut Goustave Roussy
🇫🇷
Villejuif, France