Precision Supplemental Imaging in Women With Dense Breasts

Conditions

• Breast Cancer
• Cancer of the Breast

Eligibility Criteria

Sex

FEMALE

Age

25 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• 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.
• Mammogram — DEVICE
  Standard of care annual screening mammogram
• MRI — DEVICE
  MRI at the time of annual screening mammogram

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

May 2026

Primary completion

Jun 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

78 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• 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.
• 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.
• Active Comparator: Arm B: Regular Care - annual screening mammogram
  Consenting and eligible participants will undergo annual screening mammogram per standard of care.

Primary Outcome Measure

Number of successful recommendations for MRI (Feasibility portion only) [ Time Frame: Through completion of follow-up (estimated to be 24 months) ]

Central Contacts

• Tabassum Ahmad, M.D.
  314-474-7696
  [email protected]
• Graham A Colditz, M.D., DrPH
  314-454-7939
  [email protected]

Locations (1)

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