Clinical trial NCT01303419: Contrast-Enhanced Digital Mammography (CEDM) for Identifying a Change in Management of Women With Newly Diagnosed Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: mammography
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2011-02-24
Enrollment: 224
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).

Detailed 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.

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).

Primary outcomes:
measure: Completion of CE-BMRI and DE-CEDM
timeFrame: Approximately 8 weeks
measure: Average Maximum Lesion Size by CE-BMRI Scan
timeFrame: Within 1 week of CE-BMRI scan
measure: Average Maximum Lesion Size by DE-CEDM
timeFrame: Within 1 week of DE-CEDM scan
measure: Average Maximum Lesion Size by Histology Outcome
timeFrame: Approximately 1 week; upon completion of histology report
measure: Multi-reader Evaluation of Images
timeFrame: This outcome did not occur due to premature study stop.
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Brugge
country: Belgium
facility: AZ St-Jan Brugge AV
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
city: Villejuif
country: France
facility: Institut Goustave Roussy
city: Berlin
country: Germany
facility: Institut fur Radiologie, Charite
Study officials:
References: