Precision Supplemental Imaging in Women With Dense Breasts
Trial statusRecruiting
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
This trial accepts healthy volunteersQualifiers
Normal screening mammogram within 90 days prior to enrollment. Bi-Rads of 1 or 2.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Prognosia Breast
DeviceThe 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.
Mammogram
DeviceStandard of care annual screening mammogram
MRI
DeviceMRI at the time of annual screening mammogram
Treatment groups
78 Participants
are divided into 3 treatment groupsGroup A: Feasibility: Recommended MRIExperimental treatment 3 interventions
Group B: Arm A: Intervention - MRI + subsequent annual screening mammogram with MRIExperimental treatment 3 interventions
Group C: Arm B: Regular Care - annual screening mammogramActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of successful recommendations for MRI (Feasibility portion only)
Successful recommendation of MRI is defined as completion of MRI by women referred for MRI.
Time frame
Through completion of follow-up (estimated to be 24 months)2
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
Time frame
2 yearsSecondary outcomes
1
Sample size for randomized controlled trial (Feasibility portion only)
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.
Time frame
Through completion of follow-up (estimated to be 24 months)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)Sponsors and contacts
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Source ClinicalTrials.gov