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NCT Number: NCT07277738

Precision Supplemental Imaging in Women With Dense Breasts

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer of the Breast Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: MRS, Mammogram absolute risk score

Mammogram

Device

Standard of care annual screening mammogram

MRI

Device

MRI at the time of annual screening mammogram

Other names: Magnetic resonance imaging

Primary outcomes

  1. Number of successful recommendations for MRI (Feasibility portion only)

    Time frame: Through completion of follow-up (estimated to be 24 months)

    Successful recommendation of MRI is defined as completion of MRI by women referred for MRI.

  2. 2-year detection rate (Randomized Controlled Trial only)

    Time frame: 2 years

    Events including interval breast cancer or invasive breast cancer of a size ≥15mm or being lymph node positive, by arm

Secondary outcomes

  1. Sample size for randomized controlled trial (Feasibility portion only)

    Time frame: Through completion of follow-up (estimated to be 24 months)

    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.

  2. Number and percentage of recalls (Feasibility portion only)

    Time frame: Through completion of follow-up (estimated to be 24 months)

  3. Positive predictive value for recall for additional testing and biopsy (Feasibility portion only)

    Time frame: Through completion of follow-up (estimated to be 24 months)

  4. Number and percentage of recalls (Randomized Controlled Trial only)

    Time frame: Through completion of follow-up (estimated to be 24 months)

  5. Positive predictive value for recall for additional testing and biopsy (Randomized Controlled Portion only)

    Time frame: Through completion of follow-up (estimated to be 24 months)

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Precision Supplemental Imaging in Women With Dense Breasts (PSID Trial)

Acronym: PSID

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Dec 11, 2025
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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