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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01303419
First received: February 18, 2011
Last updated: October 31, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Other: DE-CEDM and CE-BMRI
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • DE-CEDM - CE-BMRI Comparison for the identification of women whose clinical management would be changed. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 350
Study Start Date: April 2010
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: DE-CEDM and CE-BMRI
    Comparison between DE-CEDM and CE-BMRI
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303419

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

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01303419     History of Changes
Other Study ID Numbers: DE-CEDM-001
Study First Received: February 18, 2011
Last Updated: October 31, 2012
Health Authority: France: Institutional Ethical Committee
Belgium: Ethics Committee
Germany: Ethics Commission
Canada: Ethics Review Committee
United States: Institutional Review Board

Keywords provided by GE Healthcare:
mammography

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

ClinicalTrials.gov processed this record on May 19, 2013