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

Stopped early · Not applicable

Conditions studied: Breast Cancer

In brief

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).

Key facts

Study ID

NCT01303419

Run by

GE Healthcare

People needed

224

Starts

2010-04-01

Expected to finish

2012-06-30

Last updated by the study team

2019-04-10

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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