Breast Cancer
Conditions
Keywords
Breast Cancer, screening, breast MRI, contrast enhanced spectral mammography
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.
Interventions
DEVICECESM
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
DEVICEMRI
MRI uses magnets to create a detailed image of the tissues and bones inside of the body
Sponsors
GE Healthcare
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening | 2 years | We will determine whether CESM is non-inferior to breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening | 2 years | Radiologist readers evaluated CEM and abbreviated MRI in 132 patients, some who had cancer and some who did not. The area under the curve was determine for each reader for each exam type. |
| Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening | 2 years | We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model. |
Countries
United States
Participant flow
Recruitment details
132
Pre-assignment details
132 patients were included in the reader study. 42 patients had imaging acquired as part of clinical trial NCT02275871, 78 as part of clinical trial NCT03482557, and 12 as part of clinical care.
Participants by arm
| Arm | Count |
|---|---|
| Screening CESM and Breast MRI Each enrolled participant will receive both a CESM and MRI exam either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the CEM and MRI must be performed prior to biopsy. | 132 |
| Total | 132 |
Baseline characteristics
| Characteristic | Screening CESM and Breast MRI | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 16 Participants | — |
| Age, Categorical Between 18 and 65 years | 116 Participants | — |
| Age, Continuous | 54 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 132 Participants | — |
| Sex: Female, Male Female | 132 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 132 | 0 / 132 |
| other Total, other adverse events | 0 / 132 | 0 / 132 |
| serious Total, serious adverse events | 0 / 132 | 0 / 132 |
Outcome results
Primary
Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening
We will determine whether CESM is non-inferior to breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.
Time frame: 2 years
Population: Images from 78 patients were included from prospective recruitment, images from 42 patients from prior research (NCT02275871), and images from 12 patients from clinical care.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cancers Identified With CESM | Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening | 0.91 Probability of malignancy |
| Cancers Identified With Screening MRI | Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening | .91 Probability of malignancy |
Secondary
Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening
Radiologist readers evaluated CEM and abbreviated MRI in 132 patients, some who had cancer and some who did not. The area under the curve was determine for each reader for each exam type.
Time frame: 2 years
Population: Images from 78 patients were included from prospective recruitment, images from 42 patients from prior research (NCT02275871), and images from 12 patients from clinical care.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cancers Identified With CESM | Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening | .906 Probability of malignancy |
| Cancers Identified With Screening MRI | Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening | .894 Probability of malignancy |
Secondary
Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening
We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model.
Time frame: 2 years
Population: Images from 78 patients were included from prospective recruitment, images from 42 patients from prior research (NCT02275871), and images from 12 patients from clinical care.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cancers Identified With CESM | Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening | .906 Probability of malignancy |
| Cancers Identified With Screening MRI | Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening | .788 Probability of malignancy |