Efficacy of Tomosynthesis in the BIRADS 3 Population (BIRADS)

January 5, 2011 updated by: WellSpan Health

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

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Study Type

Observational

Enrollment (Anticipated)

690

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Breast cancer Patients in treatment or post-treatment for breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
to see if Breast Tomosynthesis, a three-dimensional (3D) imaging study is more accurate than standard mammography (a two-dimensional (2D) study). Time Frame: 5 years	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WellSpan Health

Collaborators

Hologic, Inc.

Investigators

Principal Investigator: Joanne Trapeni, DO, Wellspan Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria