Efficacy of Tomosynthesis in the BIRADS 3 Population

NCT00763100 | Completed DMC

• 1 other identifier: 0708023
• Study Type: observational
• Target: 690
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer

Keywords

Breast cancer; Three dimensional versus two dimensional; Breast cancer surveillance; Tomosynthesis

Outcome Measures

Primary Outcomes (1)

• to see if Breast Tomosynthesis, a three-dimensional (3D) imaging study is more accurate than standard mammography (a two-dimensional (2D) study).

  5 years

Study Arms (1)

Breast cancer

Patients in treatment or post-treatment for breast cancer

Eligibility Criteria

• Age: 26 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three groups of patients will be enrolled: Group 1 will enroll patients that have been categorized as a BIRADS 3 on the basis of screening and diagnostic conventional imaging work-up. Group II will enroll patients that have been categorized as a BIRADS 3 for surveillance imaging because they have undergone breast conservation therapy for breast cancer. Group III will enroll patients that have been categorized as a BIRADS 3 for surveillance imaging because they are currently undergoing primary systemic therapy.

You may qualify if:

• GROUP 1
• female of any race and ethnicity
• 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
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• WellSpan Health: lead
• Hologic, Inc.: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Joanne Trapeni, DO

  WellSpan Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 6, 2011

Record last verified: 2011-01