Breast Cancer Clinical Trial
Official title:
To Determine the Clinical Impact of the Combination of Digital Breast Tomosynthesis and Digital Mammography on Screening for Breast Cancer
NCT number | NCT01593384 |
Other study ID # | CASE2112 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | May 4, 2012 |
Last updated | February 15, 2016 |
Start date | April 2012 |
Digital Breast Tomosynthesis (DBT) is a technology that has been developed to improve lesion detection in dense breasted women. Even though DBT has been regarded as a study for dense breasted women, it may also improve lesion detection at an earlier stage and smaller size in women with less dense breast tissue. The overlapping of tissue on a standard of care 2D mammogram leads to decreased cancer detection, it also contributes to pseudo lesions that mimic cancers. This leads to patients being asked to come back for additional imaging including mammogram and/or ultrasound images. DBT has shown to decrease call back rates by up to 43% in reader studies. Even though these results are promising they were not done in a realistic clinical setting.The purpose of this study is to evaluate the FDA-approved combination standard digital mammography (DM) and DBT technology and its impact on our clinical practice.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 30 Years and older |
Eligibility |
Inclusion Criteria: - Female ages 30 and over - Asymptomatic - Any ethnic origin - No contraindication for routine bilateral mammogram Exclusion Criteria: - Pregnancy - Lactating patients - Breast implants - Unable to understand and execute written informed consent - Patient unable to obtain a mammogram while standing without assistance |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure the impact on recall rates, comparing DM and DM+DBT | Measure the impact on recall rates, comparing DM and DM+DBT, in our practice and the impact on cancer detection in our screening population. | 3 yrs | No |
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