Study Summary
This trial compares the effectiveness of two breast cancer screening methods: molecular breast imaging (MBI) and digital breast tomosynthesis (DBT).
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: 1 year
1 year
Invasive Cancer Detection Rate
Year 1
Change in advanced cancer rate with incorporation of MBI screening
Rate of interval cancers with incorporation of MBI screening
Reduction in advanced cancer rate with incorporation of MBI screening
Relative performance of DBT and MBI within subgroups categorized by breast cancer risk
Screening performance metrics of biopsy rate
Screening performance metrics of positive predictive value and negative predictive value
Screening performance metrics of recall rate
Screening performance metrics of sensitivity
Screening performance metrics of specificity
At year 0 screening
Rate of detection of invasive cancers
At year 1 screening
Characteristics of all cancers (invasive and noninvasive) detected on DBT and MBI
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Observational (MRI, DBT)
1 of 1
Experimental Treatment
3000 Total Participants · 1 Treatment Group
Primary Treatment: Digital Tomosynthesis Mammography · No Placebo Group · N/A
Observational (MRI, DBT)Experimental Group · 2 Interventions: Scintimammography, Digital Tomosynthesis Mammography · Intervention Types: Radiation, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital Tomosynthesis Mammography
2017
N/A
~50
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Who is running the clinical trial?
Mayo ClinicLead Sponsor
2,922 Previous Clinical Trials
3,514,153 Total Patients Enrolled
83 Trials studying Breast Cancer
14,027 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,084 Previous Clinical Trials
41,138,646 Total Patients Enrolled
925 Trials studying Breast Cancer
1,533,366 Patients Enrolled for Breast Cancer
Carrie Hruska, PhDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
325 Total Patients Enrolled
1 Trials studying Breast Cancer
25 Patients Enrolled for Breast Cancer
Carrie B HruskaPrincipal InvestigatorMayo Clinic in Rochester
Eligibility Criteria
Age 40 - 75 · Female Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patient is able to participate fully in all aspects of the study.
Patient anticipates being able to return one year after study enrollment to complete the second round of screening.
You have a female age 40-75 years.
You have no symptoms of breast disease.
Patient had heterogeneously dense or extremely dense breasts on most recent prior mammography examination (Breast Imaging Reporting and Data System [BI-RADS] c or d) within 24 months of enrollment.
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Conditions
Cancer Related
Treatments