Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 9/27/2017 |
| Start Date: | April 2010 |
| End Date: | June 30, 2012 |
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.
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.
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).
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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