Breast Cancer Clinical Trial

Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer

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).

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Full 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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Eligibility 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).

Study is for people with:

Breast Cancer

Estimated Enrollment:

224

Study ID:

NCT01303419

Recruitment Status:

Terminated

Sponsor:

GE Healthcare

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There is 1 Location for this study

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Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
AZ St-Jan Brugge AV
Brugge , , Belgium
Sunnybrook Health Science Centre
Toronto , , Canada
Institut Goustave Roussy
Villejuif , , France
Institut fur Radiologie, Charite
Berlin , , Germany

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

224

Study ID:

NCT01303419

Recruitment Status:

Terminated

Sponsor:


GE Healthcare

How clear is this clinincal trial information?

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