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

January 29, 2018 updated by: University of California, Irvine
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Breast Health Center, University of California Irvine Medical Center

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

38 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Requirements

  • 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

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: DIRECTVIEW CR Mammography
4 views screening mammogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To collect mammogram from patients with breast cancer using the Carestream Mammo CR device.
Time Frame: at completion of the study
at completion of the study

Collaborators and Investigators

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

Sponsor

University of California, Irvine

Collaborators

Carestream Health, Inc.
Eastman Kodak Company

Investigators

  • Principal Investigator: Stephen Feig, MD, University of California, Irvine

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, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 12, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimate)

February 8, 2008

Study Record Updates

Last Update Posted (Actual)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • UCI-HS-2007-5519
  • CH-41914 (Other Grant/Funding Number: Carestream Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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