Precision Supplemental Imaging in Women With Dense Breasts (PSID)

The Washington University

Status: Begins enrollment in 1 month

Conditions: Breast Cancer; Cancer of the Breast

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07277738

202511123

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: Female

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 3 patient groups

Feasibility: Recommended MRI

Experimental group

Description:

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

Treatment:

Device: Mammogram

Device: Prognosia Breast

Device: MRI

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

Experimental group

Description:

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

Treatment:

Device: Mammogram

Device: Prognosia Breast

Device: MRI

Arm B: Regular Care - annual screening mammogram

Active Comparator group

Description:

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

Treatment:

Device: Mammogram