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

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

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).

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Device: CE-BMRI; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium
    • AZ St-Jan Brugge AV
• Canada
  • Toronto, Canada
    • Sunnybrook Health Science Centre
• France
  • Villejuif, France
    • Institut Goustave Roussy
• Germany
  • Berlin, Germany
    • Institut fur Radiologie, Charite
• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: CE-BMRI; Contrast-enhanced breast imaging using Magnetic Resonance; Device: DE-CEDM; Breast imaging using Dual-energy, contrast-enhanced digital mammography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): June 30, 2012
• Study Completion (Actual): June 30, 2012

Study Registration Dates

• First Submitted: February 18, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: mammography
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: DE-CEDM-001