Precision Supplemental Imaging in Women With Dense Breasts
NCT ID: NCT07277738
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
78 participants
INTERVENTIONAL
2025-12-31
2028-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Feasibility: Recommended MRI
Consenting and eligible participants will be recommended to undergo MRI and will be followed to determine whether they complete the MRI.
Prognosia Breast
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.
Mammogram
Standard of care annual screening mammogram
MRI
MRI at the time of annual screening mammogram
Arm A: Intervention - MRI + subsequent annual screening mammogram with MRI
Consenting and eligible participants will undergo an MRI and subsequent annual screening mammogram with MRI.
Prognosia Breast
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.
Mammogram
Standard of care annual screening mammogram
MRI
MRI at the time of annual screening mammogram
Arm B: Regular Care - annual screening mammogram
Consenting and eligible participants will undergo annual screening mammogram per standard of care.
Mammogram
Standard of care annual screening mammogram
Interventions
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Prognosia Breast
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.
Mammogram
Standard of care annual screening mammogram
MRI
MRI at the time of annual screening mammogram
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Dense breasts, either:
* Class C density ("the breasts are heterogeneously dense, which may obscure small masses")
* Class D density ("the breasts are extremely dense, which lowers the sensitivity of mammography")
* 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
* Contraindication to MRI with contrast (e.g. claustrophobia, metal objects in the body, known sensitivity/allergy to gadolinium).
* Prior or concurrent malignancy whose natural history has the potential to interfere with the study intervention (breast cancer or LCIS). Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
* Prior MRI screening of the breast.
* Known to be BRCA 1/2 positive or presence of any other known high penetrance genetic marker.
* Is receiving any chemoprevention.
* Has breast implants.
* Is breastfeeding.
25 Years
55 Years
FEMALE
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Tabassum Ahmad, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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202511123
Identifier Type: -
Identifier Source: org_study_id
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