Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
| Dana-Farber Cancer Institute | OTHER |
Not provided
Not provided
Not provided
This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast-Enhanced Spectral Mammography | Experimental | Each enrolled participant will receive a CESM either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the CESM must be performed prior to biopsy. |
|
| Breast MRI | Experimental | Each enrolled participant will receive an 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 MRI must be performed prior to biopsy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CESM | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olga Brook, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess | Boston | Massachusetts | 02215 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
132
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Screening CESM and 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Probability of malignancy | 2 years |
|
Adverse Data were collected at the time of any research imaging exams that were acquired and within 1 year of the exam.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Screening CESM Before Biopsy | Each enrolled participant will receive both a CESM and MRI exam prior to the breast biopsy, if they had not been performed already as part of clinical care. MRI: Breast MRI will be performed, if not already performed as part of clinical care. CESM: After the MRI is complete, patients will be brought to the mammography department for the contrast enhanced mammogram. The CESM will only occur if not already performed as part of the patient's clinical care. Biopsy: Patients will then have their biopsy. Any additional findings seen on the CESM or MRI will be worked up also. Reader Study: The CESM and the MRI images will be included in a case set that is ready by 10 study radiologists at a later date, after the biopsy is performed. These radiologists will look at the images to see if CESM and MRI find the same number of breast cancers. CESM: 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 MRI: MRI uses magnets to create a detailed image of the tissues and bones inside of the body |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Mccall | Beth Israel Deaconess MEdical Center | 617-418-9216 | mmccall1@bidmc.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 24, 2023 | Oct 21, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2023 | Aug 13, 2024 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| MRI | Device | MRI uses magnets to create a detailed image of the tissues and bones inside of the body |
|
|
| 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. |
| 2 years |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Cancers Identified With Screening MRI |
Recruited patient images were added to other patient images who had both CEM and MRI before biopsy. The images were included in a reader study evaluating diagnostic accuracy of CEM vs MRI |
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Probability of malignancy | 2 years |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Probability of malignancy | 2 years |
|
|
|
| 0 |
| 132 |
| 0 |
| 132 |
| 0 |
| 132 |
| EG001 | Screening MRI Before Biopsy | Each enrolled participant will receive both a CESM and MRI exam prior to the breast biopsy, if they had not been performed already as part of clinical care. MRI: Breast MRI will be performed, if not already performed as part of clinical care. CESM: After the MRI is complete, patients will be brought to the mammography department for the contrast enhanced mammogram. The CESM will only occur if not already performed as part of the patient's clinical care. Biopsy: Patients will then have their biopsy. Any additional findings seen on the CESM or MRI will be worked up also. Reader Study: The CESM and the MRI images will be included in a case set that is ready by 10 study radiologists at a later date, after the biopsy is performed. These radiologists will look at the images to see if CESM and MRI find the same number of breast cancers. CESM: 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 MRI: MRI uses magnets to create a detailed image of the tissues and bones inside of the body | 0 | 132 | 0 | 132 | 0 | 132 |
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |