Efficacy of Tomosynthesis in the BIRADS 3 Population

NCT ID: NCT00763100

Last Updated: 2011-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

690 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast cancer

Patients in treatment or post-treatment for breast cancer

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

26 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hologic, Inc.

INDUSTRY

Sponsor Role collaborator

WellSpan Health

OTHER

Sponsor Role lead

Responsible Party

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Women's Imaging Center

Principal Investigators

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Joanne Trapeni, DO

Role: PRINCIPAL_INVESTIGATOR

WellSpan Health

Other Identifiers

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0708023

Identifier Type: -

Identifier Source: org_study_id

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