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
21 Years
N/A
Female
Breast Cancer
Trial Information
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
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).
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
DE-CEDM - CE-BMRI Comparison for the identification of women whose clinical management would be changed.
Outcome Description:
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).
Outcome Time Frame:
15 months
Safety Issue:
No
Authority:
France: Institutional Ethical Committee
Study ID:
DE-CEDM-001
NCT ID:
NCT01303419
Start Date:
April 2010
Completion Date:
Related Keywords:
- Breast Cancer
- mammography
- Breast Neoplasms
Name | Location |
|---|---|
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
