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Xpress Digital Mammography System Images for Computer Aided Detection Development

NCT ID: NCT01061138

Last Updated: 2012-12-04

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

597 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-10-31

Brief Summary

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The primary objective of this study is to acquire digital mammography images produced by the Xpress Digital Mammography System in order to develop Computer Aided Detection software and systems.

Detailed Description

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The proposed study is an image acquisition study of mammograms produced by the investigational digital system. Women who meet the selection criteria and who agree to participate in the study will be imaged with the Xpress Digital Mammography System at the clinical sites. These images will be provided to CAD development companies to conduct their own development and testing. The CAD development companies will be responsible for submitting their results to the FDA for marketing approval of their CAD systems.

Patients will be drawn primarily from those women scheduled for breast biopsy since this population has an enhanced probability of cancer. The intent is to enroll patients until at least 107 women with biopsy proven cancers, and at least 330 women who have negative mammograms are enrolled. All cancers found will be used in the study. It is anticipated that approximately 720 patients undergoing diagnostic mammography will need to be enrolled to yield 107 proven cancer cases. In addition, approximately 330 cases will be drawn from a screening population. The negative status of the screening cases will be established by selecting only cases classified as BIRADS 1 or 2, and have a negative mammogram at one year follow-up. All images collected will be utilized to develop and test the CAD systems, and may be used for further product development.

Conditions

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Breast Cancer

Keywords

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breast cancer screening mammograms breast biopsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Screening Patients

Female patients scheduled for routine annual screening mammograms

No interventions assigned to this group

Biopsy Patients

Female patients scheduled for routine breast biopsy procedures

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Cases selected for the study must meet all of the following criteria:

* Female
* Scheduled for a routine screening mammography or routine breast biopsy for non-palpable findings
* Any ethnic origin

Exclusion Criteria

Patients meeting any of the following criteria will be excluded from the study:

* Any contraindication to mammography
* Pregnant or suspicion of being pregnant, or nursing
* Patients with palpable lesions
* Patients with internal breast markers in the region of interest
* Breast implants, without displaced views
* Significant recent breast trauma/acute mastitis
* Patient has previously undergone an excisional breast biopsy
* Patients with a history of breast cancer
* Unable or unwilling to give consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Konica Minolta Medical Imaging, USA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Etta Pisano, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Waterbury Hospital

Waterbury, Connecticut, United States

Site Status

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Greenville Hospital Systems

Greenville, South Carolina, United States

Site Status

University of Texas San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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#03

Identifier Type: -

Identifier Source: org_study_id