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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.
 
ClinicalTrials.gov Identifier: NCT01303419
Recruitment Status : Terminated (Sponsor determined there was sufficient material collected to answer the study questions.)
First Posted : February 24, 2011
Results First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Brief Summary:
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).

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: N/A
Intervention Model: Single Group 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
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




Primary Outcome Measures :
  1. Completion of CE-BMRI and DE-CEDM [ Time Frame: Approximately 8 weeks ]
    Subjects have completed both CE-BMRI and DE-CEDM scan types

  2. Average Maximum Lesion Size by CE-BMRI Scan [ Time Frame: Within 1 week of CE-BMRI scan ]
    Average maximum lesion size when scanned using CE-BMRI

  3. Average Maximum Lesion Size by DE-CEDM [ Time Frame: Within 1 week of DE-CEDM scan ]
    Average maximum lesion size when scanned using DE-CEDM

  4. Average Maximum Lesion Size by Histology Outcome [ Time Frame: Approximately 1 week; upon completion of histology report ]
    Average maximum lesion size as described in histology report.

  5. Multi-reader Evaluation of Images [ Time Frame: This outcome did not occur due to premature study stop. ]
    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.



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

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
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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
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01303419    
Other Study ID Numbers: DE-CEDM-001
First Posted: February 24, 2011    Key Record Dates
Results First Posted: April 10, 2019
Last Update Posted: April 10, 2019
Last Verified: March 2019
Keywords provided by GE Healthcare:
mammography
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases