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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 25 Years and 55 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Normal screening mammogram within 90 days prior to enrollment. Bi-Rads of 1 or 2. - 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") - Assigned female at birth. - Between 40 to 74 years of age (inclusive). - Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria

  • Screening mammogram with BI-Rads of 0. - 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 non-classic 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 endocrine therapy. - Has breast implants. - Is breastfeeding.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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.
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Feasibility: Recommended MRI 		Consenting and eligible participants will be recommended to undergo MRI and will be followed to determine whether they complete the MRI.
  • Device: 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.
    Other names:
    • MRS
    • Mammogram absolute risk score
  • Device: Mammogram
    Standard of care annual screening mammogram
  • Device: MRI
    MRI at the time of annual screening mammogram
    Other names:
    • Magnetic resonance imaging
Experimental
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.
  • Device: 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.
    Other names:
    • MRS
    • Mammogram absolute risk score
  • Device: Mammogram
    Standard of care annual screening mammogram
  • Device: MRI
    MRI at the time of annual screening mammogram
    Other names:
    • Magnetic resonance imaging
Active Comparator
Arm B: Regular Care - annual screening mammogram 		Consenting and eligible participants will undergo annual screening mammogram per standard of care.
  • Device: Mammogram
    Standard of care annual screening mammogram

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Tabassum Ahmad, M.D.
314-474-7696
ahmad.tabassum@wustl.edu

More Details

NCT ID
NCT07277738
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Tabassum Ahmad, M.D.
314-474-7696
ahmad.tabassum@wustl.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.