Clinical trial NCT03482557: Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening
Official title: Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
screening
breast MRI
contrast enhanced spectral mammography
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: GE Healthcare
name: Dana-Farber Cancer Institute
First posted: 2018-03-29
Enrollment: 132
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening

Detailed description: Mammography is the main way to help find breast cancers early so they can be treated. Unfortunately, mammography does not work as well in women who have dense breast tissue or who are at high-risk for breast cancer. In these women, breast MRI is also used to help find breast cancers.

Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. This is similar to breast MRI.

For this study, participants who had both CEM and MRI evaluating a finding that initiated from a screening exam will be included. Radiologists will compare the images to see if the contrast enhanced mammograms and the breast MRI find the same number of breast cancers. If the investigators find they perform similarly, then contrast mammography may be used to aid in breast cancer screening in the future.

Eligibility criteria: Inclusion Criteria:

* CESM and MRI exam performed within 3 months of one another.
* CESM and breast MRI exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)
* CESM studies will include at least four low energy and four recombined images (LCC, LMLO, RCC, RMLO).
* MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted

Exclusion Criteria:

* Imaging sets with implants.
* Imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study MRI or CESM.
* Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2 year imaging follow-up is not available

Primary outcomes:
measure: Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening
timeFrame: 2 years
Secondary outcomes:
measure: Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening
timeFrame: 2 years
measure: Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Olga Brook, MD
role: PRINCIPAL_INVESTIGATOR
References: