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

GE Healthcare224 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

224

Conditions

Breast Cancer

Interventions

CE-BMRIDEVICE

Contrast-enhanced breast imaging using Magnetic Resonance

DE-CEDMDEVICE

Breast imaging using Dual-energy, contrast-enhanced digital mammography

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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).

Locations (5)

Seattle Cancer Care Alliance

Seattle, Washington, United States

AZ St-Jan Brugge AV

Bruges, Belgium

Sunnybrook Health Science Centre

Toronto, Canada

Institut Goustave Roussy

Villejuif, France

Institut fur Radiologie, Charite

Outcomes

Primary Outcomes

Completion of CE-BMRI and DE-CEDM

Subjects have completed both CE-BMRI and DE-CEDM scan types

Time frame: Approximately 8 weeks

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

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

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

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.

Data from ClinicalTrials.gov

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