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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 determined there was sufficient material collected to answer the study questions.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01303419
First Posted: February 24, 2011
Last Update Posted: September 25, 2017
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.
Information provided by (Responsible Party):
GE Healthcare
  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
Breast Cancer Device: CE-BMRI Device: DE-CEDM

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 ]
    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).


Enrollment: 224
Study Start Date: April 2010
Study Completion Date: June 30, 2012
Primary Completion Date: June 30, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT01303419


Locations
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Belgium
AZ St-Jan Brugge AV
Brugge, 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

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01303419     History of Changes
Other Study ID Numbers: DE-CEDM-001
First Submitted: February 18, 2011
First Posted: February 24, 2011
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by GE Healthcare:
mammography

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