Efficacy of Tomosynthesis in the BIRADS 3 Population

Breast Cancer Clinical Trial

— BIRADS  

Official title:

The Efficacy of Tomosynthesis in the BIRADS 3 Population Including Surveillance of Patients in the Treatment or Post-Treatment for Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763100
• Other study ID #: 0708023
• Status: Completed
• Phase: N/A
• First received: September 26, 2008
• Last updated: January 5, 2011
• Start date: May 2008
• Est. completion date: November 2009

Study information

• Verified date: January 2011
• Source: WellSpan Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

There are three main objectives, centering on those patients targeted for surveillance imaging. The first objective is to compare image quality and specificity of breast tomosynthesis and conventional 2D mammography in a BIRADS 3 diagnostic population. The second objective is to compare image quality and ability to determine post-surgical and post-radiation changes from recurrence in a post-cancer subset of a BIRADS 3 population having undergone conservation therapy (lumpectomy with or without radiation. The final objective is to compare image quality and the ability to determine chemoresponsiveness in a post-cancer subset of a BIRADS 3 population, who are undergoing neoadjuvant chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 690
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 26 Years and older

Eligibility

Inclusion Criteria:

GROUP 1

• female of any race and ethnicity

• 35 years or older

• after routine and diagnostic imaging, subject is categorized as a BI-RADS 3 and will undergo study imaging within 30 days of routine or diagnostic imaging.

• subject is returning for surveillance imaging after a categorization of a BI-RADS 3 and will undergo study imaging within 30 days of surveillance imaging GROUP 2

• female of any race and ethnicity

• 26 years or older

• subject has completed cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging

• subject will undergo study imaging within 30 days of surveillance imaging GROUP 3

• female of any race and ethnicity

• 26 years or older

• subject is currently undergoing cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging OR

• subject will undergo study imaging within 30 days of surveillance imaging

Exclusion Criteria:

• GROUP 1, 2 and 3

• subjects unable or unwilling to participate

• subjects who are unable or unwilling to tolerate compression

• subjects who are pregnant or who think they may be pregnant

• subjects who are breastfeeding

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
WellSpan Health	Hologic, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to see if Breast Tomosynthesis, a three-dimensional (3D) imaging study is more accurate than standard mammography (a two-dimensional (2D) study).		5 years	No