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

February 18, 2011
October 31, 2012
April 2010
October 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01303419 on ClinicalTrials.gov Archive Site
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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 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.

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Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Breast Cancer
Other: DE-CEDM and CE-BMRI
Comparison between DE-CEDM and CE-BMRI
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
350
Not Provided
October 2012   (final data collection date for primary outcome measure)

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).
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   France,   Germany
 
NCT01303419
DE-CEDM-001
No
GE Healthcare
GE Healthcare
Not Provided
Not Provided
GE Healthcare
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP