Testing Digital Breast Tomosynthesis vs. Regular Mammogram in Detecting Breast Cancer in Women Having Screening Mammogram

NCT ID: NCT00535678

Last Updated: 2010-05-14

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

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-07-31

Brief Summary

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To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Women ≥18 years or older for screening mammography
* Able and willing to comply with study procedures, and have signed and dated the informed consent form
* The subject is surgically sterile or postmenopausal

Exclusion Criteria

* Pregnant or trying to become pregnant
* Has signs or symptoms of breast cancer
* Has been previously included in this study
* Has breast implants
* Has a history of breast cancer and is in active treatment
* Has breasts too large to be adequately positioned for the DBT examination
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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GE Healthcare

Principal Investigators

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Amy Longcore

Role: STUDY_DIRECTOR

GE Healthcare

Locations

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GE Healthcare

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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GE 190-001

Identifier Type: -

Identifier Source: org_study_id

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