Computed Radiography (CR) Data Collection for Mammography Computer Aided Detection (CAD)

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-06-30

Brief Summary

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The objective of this study is to collect an image library of diagnostic digital mammograms using the Carestream CR mammography system from patients who have histological-conformed breast cancer to demonstrate the clinical feasibility of this system for detection of breast cancer.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DirectView CR Mammography

Each subject will have routine clinical care imaging obtained and 4 standard mammogram views (RMLO, RCC, LMLO, LCC) using CR mammography. If routine mammograms were obtained on a day previous to enrollment in the study, those images (4 views; 2 views for mastectomy patients) will not be repeated for this study; only the CR images will be obtained.

Group Type EXPERIMENTAL

DIRECTVIEW CR Mammography

Intervention Type DEVICE

4 views screening mammogram

Interventions

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DIRECTVIEW CR Mammography

4 views screening mammogram

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women age 40 to 85
* Recommended for biopsy and BI-RADS assessment of category 4 (suspicious abnormality) or 5 (highly suggestive of malignancy)
* Able to have MLO and CC views taken
* Good general health
* Able and willing to provide a written Informed Consent

Exclusion Requirements

* Under age 40
* Pregnant or suspicious of being pregnant
* Breast implants
* Breasts too large to be adequately positioned on a 24 x 30 cassette
* Personal history of breast cancer treated with a lumpectomy
* Unable or unwilling to provide a written Informed Consent form

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No