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

NCT01593384 | Withdrawn

• 1 other identifier: CASE2112
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Digital Breast Tomosynthesis (DBT); Digital Mammography (DM)

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects from routine clinical patient population at our medical facility. There will be inclusion of employees and students in the study. A number of UHCMC employees and a few CWRU students are in our routine clinical patient population.

You may qualify if:

• Female ages 30 and over
• Asymptomatic
• Any ethnic origin
• No contraindication for routine bilateral mammogram

You may not qualify if:

• Pregnancy
• Lactating patients
• Breast implants
• Unable to understand and execute written informed consent
• Patient unable to obtain a mammogram while standing without assistance

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Donna Plecha, MD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2012
• First Posted: May 8, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2013
• Last Updated: February 17, 2016

Record last verified: 2016-02