Precision Supplemental Imaging in Women With Dense Breasts
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-55
SponsorWashington University School of Medicine
About this 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.
Eligibility criteria
Qualifiers
Normal screening mammogram within 90 days prior to enrollment.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Prognosia Breast
- Mammogram
- MRI
Treatment groups
78 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov