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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01303419
Recruitment Status : Terminated (Sponsor determined there was sufficient material collected to answer the study questions.)
First Posted : February 24, 2011
Last Update Posted : September 25, 2017
Information provided by (Responsible Party):
GE Healthcare

Brief Summary:
Enrolled women will undergo a bilateral 2-view DE-CEDM examination after administration of an iodinated contrast agent. Separate readers on-site will evaluate DE-CEDM+MX (standard mammography) and CE-BMRI+MX to determine the extent of disease. An integrated reading of both sets of images will be performed either by one or the two readers. DE-CEDM will not be used to change the diagnosis. Lesions that are confirmed as suspicious by MX, CE-BMRI, or follow-up breast ultrasound (US) will undergo biopsy. Truth about extent of disease will be based on histologic analysis of surgical specimens along with follow-up MX 10-15 months after the study exam. A randomized, blinded image evaluation will be done with 11 to 15 radiologist readers to compare DE-CEDM+MX and CE-BMRI+MX for assessment of disease extent.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: CE-BMRI Device: DE-CEDM Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : April 2010
Actual Primary Completion Date : June 30, 2012
Actual Study Completion Date : June 30, 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: CE-BMRI
Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis.
Device: CE-BMRI
Contrast-enhanced breast imaging using Magnetic Resonance

Experimental: DE-CEDM
Subject will undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.
Device: DE-CEDM
Breast imaging using Dual-energy, contrast-enhanced digital mammography

Primary Outcome Measures :
  1. DE-CEDM - CE-BMRI Comparison for the identification of women whose clinical management would be changed. [ Time Frame: 15 months ]
    DE-CEDM - CE-BMRI Comparison for the identification of women whose clinical management would be changed (defined as: presence of additional foci in the contralateral breast, and/or presence of additional foci at least 2 cm from the primary cancer in the ipsilateral breast, and/or change in size of the primary by at least 2 cm).

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01303419

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

Responsible Party: GE Healthcare Identifier: NCT01303419     History of Changes
Other Study ID Numbers: DE-CEDM-001
First Posted: February 24, 2011    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by GE Healthcare:

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases