Precision Supplemental Imaging in Women With Dense Breasts (PSID)

May 18, 2026 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
        • Sub-Investigator:
          • Debbie L Bennett, M.D.
        • Sub-Investigator:
          • Jingqin (Rosy) Luo, Ph.D.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tabassum Ahmad, M.D.
        • Principal Investigator:
          • Graham A Colditz, M.D., DrPH
        • Sub-Investigator:
          • Shu (Joy) Jiang, Ph.D.
        • Sub-Investigator:
          • Christine Marx

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Normal screening mammogram within 90 days prior to enrollment.

  • 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:

  • More than 1 prior mammogram
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through completion of follow-up (estimated to be 24 months)
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through completion of follow-up (estimated to be 24 months)
Number and percentage of recalls (Feasibility portion only)
Time Frame: Through completion of follow-up (estimated to be 24 months)
Through completion of follow-up (estimated to be 24 months)
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)
Through completion of follow-up (estimated to be 24 months)
Number and percentage of recalls (Randomized Controlled Trial only)
Time Frame: Through completion of follow-up (estimated to be 24 months)
Through completion of follow-up (estimated to be 24 months)
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)
Through completion of follow-up (estimated to be 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Tabassum Ahmad, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202511123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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