Precision Supplemental Imaging in Women With Dense Breasts

NCT07277738 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 202511123
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Cancer of the Breast

Keywords

Dense breasts; Abbreviated MRI; Risk assessment

Outcome Measures

Primary Outcomes (2)

• Number of successful recommendations for MRI (Feasibility portion only)

  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)

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

  2 years

Secondary Outcomes (5)

• Sample size for randomized controlled trial (Feasibility portion only)

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

• Number and percentage of recalls (Feasibility portion only)

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

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

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

• Number and percentage of recalls (Randomized Controlled Trial only)

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

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

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

Study Arms (3)

Feasibility: Recommended MRI

EXPERIMENTAL

Consenting and eligible participants will be recommended to undergo MRI and will be followed to determine whether they complete the MRI.

Device: Prognosia Breast; Device: Mammogram; Device: MRI

Arm A: Intervention - MRI + subsequent annual screening mammogram with MRI

EXPERIMENTAL

Consenting and eligible participants will undergo an MRI and subsequent annual screening mammogram with MRI.

Device: Prognosia Breast; Device: Mammogram; Device: MRI

Arm B: Regular Care - annual screening mammogram

ACTIVE COMPARATOR

Consenting and eligible participants will undergo annual screening mammogram per standard of care.

Device: Mammogram

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.

Also known as: MRS, Mammogram absolute risk score

Arm A: Intervention - MRI + subsequent annual screening mammogram with MRI; Feasibility: Recommended MRI

Mammogram DEVICE

Standard of care annual screening mammogram

Arm A: Intervention - MRI + subsequent annual screening mammogram with MRI; Arm B: Regular Care - annual screening mammogram; Feasibility: Recommended MRI

MRI DEVICE

MRI at the time of annual screening mammogram

Also known as: Magnetic resonance imaging

Arm A: Intervention - MRI + subsequent annual screening mammogram with MRI; Feasibility: Recommended MRI

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Study Officials

• Tabassum Ahmad, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tabassum Ahmad, M.D.

CONTACT

314-474-7696; ahmad.tabassum@wustl.edu

Graham A Colditz, M.D., DrPH

CONTACT

314-454-7939; colditzg@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 11, 2025
• Study Start: March 31, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• 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.

Locations

US (1)