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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


Phase 4
21 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

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 AllianceSeattle, Washington  98109