Prospective Chart-Review: Impact of Combination - Digital Breast Tomosynthesis + Digital Mammography

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01593384
• Other study ID #: CASE2112
• Status: Withdrawn
• Phase: N/A
• First received: May 4, 2012
• Last updated: February 15, 2016
• Start date: April 2012

Study information

• Verified date: February 2016
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

The investigators would like to prospectively measure the impact on recall rates, comparing DM (digital mammography) and DM+DBT, in our practice and the impact on cancer detection in our screening population. This is a two-site study in which all asymptomatic subjects undergoing the FDA-approved combination standard of care Digital Mammogram and Digital Breast Tomosynthesis (DM+DBT) exam will be eligible for the trial. Each subject will be her own control.Only radiologists who have gone through 8 hours of Tomosynthesis training will interpret the DM and DBT images. These radiologists will categorize each case as either dense (BI-RADS density score of 3 or 4) or fatty (BI-RADS density score of 1 or 2). The radiologist will initially read the standard of care DM part of the study first and record their interpretation and final BIRADs category. The same radiologist will then interpret the DM+DBT combination study and record their final interpretation and BIRADs category. Prior mammogram studies will be used for comparison when reading the DM and DM+DBT studies.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Outcome

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