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Recent research has shown that, among women with extremely dense breasts and normal results on mammogram, magnetic resonance imaging (MRI) use has significantly reduced the occurrence of breast cancer that is diagnosed during the time between two regular screening mammograms (also known as interval cancers).
The investigators have developed and validated an approach to use the whole mammogram image, develop a mammogram risk score (MRS), and calibrate this to the SEER breast cancer incidence rates for US women. This model (Prognosia Breast) generates an absolute 5-year risk of breast cancer and classifies approximately 5.7% of the population as high risk using the ASCO 3% cut point as used for endocrine therapy to reduce risk. Follow-up generates an incidence of 25.2 cases per 1,000 women per year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility: Recommended MRI | Experimental | Consenting and eligible participants will be recommended to undergo MRI and will be followed to determine whether they complete the MRI. |
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| Arm A: Intervention - MRI + subsequent annual screening mammogram with MRI | Experimental | Consenting and eligible participants will undergo an MRI and subsequent annual screening mammogram with MRI. |
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| Arm B: Regular Care - annual screening mammogram | Active Comparator | Consenting and eligible participants will undergo annual screening mammogram per standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prognosia Breast | Device | The risk output from this algorithm is calibrated to US Surveillance, Epidemiology, and End Results (SEER) 5-year risk and so estimates for each woman the personal 5-year risk. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of successful recommendations for MRI (Feasibility portion only) | Successful recommendation of MRI is defined as completion of MRI by women referred for MRI. | Through completion of follow-up (estimated to be 24 months) |
| 2-year detection rate (Randomized Controlled Trial only) | Events including interval breast cancer or invasive breast cancer of a size ≥15mm or being lymph node positive, by arm | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Sample size for randomized controlled trial (Feasibility portion only) | At the completion of the feasibility study, the investigators will use the feasibility study data to inform and calculate the sample size for the subsequent randomized 2-arm trial, and if feasible and results are promising, the investigators will propose a randomized 2-arm trial to evaluate the effectiveness of MRI screening in terms of 2-year event rate. |
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Inclusion Criteria:
Normal screening mammogram within 90 days prior to enrollment.
Dense breasts, either:
MRS risk estimate at > 3% 5-year risk of breast cancer.
Female.
Between 25 and 55 years of age (inclusive).
Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tabassum Ahmad, M.D. | Contact | 314-474-7696 | ahmad.tabassum@wustl.edu | |
| Graham A Colditz, M.D., DrPH | Contact | 314-454-7939 | colditzg@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tabassum Ahmad, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following article publication.
Proposals should be directed to the Principal Investigator. To gain access, data requestors will need to sign a data access agreement and provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008327 | Mammography |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The feasibility study will enroll 78 evaluable women and will be sequential enrollment. The sample size for the randomized controlled portion of this study will depend on the results of the feasibility portion of the study and it will be parallel enrollment.
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|
| Mammogram | Device | Standard of care annual screening mammogram |
|
| MRI | Device | MRI at the time of annual screening mammogram |
|
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| Through completion of follow-up (estimated to be 24 months) |
| Number and percentage of recalls (Feasibility portion only) | Through completion of follow-up (estimated to be 24 months) |
| Positive predictive value for recall for additional testing and biopsy (Feasibility portion only) | Through completion of follow-up (estimated to be 24 months) |
| Number and percentage of recalls (Randomized Controlled Trial only) | Through completion of follow-up (estimated to be 24 months) |
| Positive predictive value for recall for additional testing and biopsy (Randomized Controlled Portion only) | Through completion of follow-up (estimated to be 24 months) |
| D017437 |
| Skin and Connective Tissue Diseases |
| D014054 |
| Tomography |