Clinical trial NCT02275871: Comparison of Contrast-enhanced Spectral Mammography (CESM) to MRI in Screening High Risk Women for Breast Cancer
Official title: Dual-energy Contrast-enhanced Digital Subtraction Mammography (CESM) as a Tool to Screen High Risk Women for Breast Cancer: a Comparison to Screening Breast MRI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2014-10-27
Enrollment: 44
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) to MRI as a screening tool for breast cancer.

Detailed description: This research study is being done to test how well a contrast enhanced mammogram compares to MRI in screening for breast cancer in people who are at higher risk for developing breast cancer.

Standard screening mammograms can miss breast cancers due to its inability to "see through" dense breast tissue. For this reason, women at increased risk for the development of breast cancer often undergo additional screening beyond conventional mammography with magnetic resonance imaging (MRI). Although screening MRI is very sensitive for finding breast cancer, it also finds many areas that are benign (not cancer). The only way to know which is the cancer is to perform a biopsy, which contributes to patient anxiety and leads to many unnecessary biopsies.

In the preliminary studies performed in women already diagnosed with breast cancer, contrast enhanced mammography was shown to have a similar sensitivity for finding primary breast cancer but detected fewer of the benign findings which would result in fewer unnecessary biopsies. It is also a faster and less expensive exam compared to MRI. Contrast mammography was FDA approved in 2011 and is used now as a tool to help work-up abnormalities seen on standard mammography and ultrasound.

We are now studying to see if contrast enhanced mammography will also be a beneficial tool in the screening setting to screen high risk patients for breast cancer.

Eligibility criteria: Inclusion Criteria:

* Women
* Age \> or equal to 30 years
* High risk (\>20% lifetime risk)
* Has a bilateral mammogram within the last 7 months
* Has had a same day high risk screening MRI

Exclusion Criteria:

* Participants who have a known allergy or contraindication to iodinated contrast.
* Participants who have a known allergy to food or medications.
* Participants who have renal insufficiency or failure.
* Participants who are pregnant or breastfeeding.
* Participants with a concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.

Primary outcomes:
measure: Number of cancers and false positive findings identified on CESM versus MRI as a measure of sensitivity and specificity
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Jordana Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References: