Xpress Digital Mammography System Images for Computer Aided Detection Development

December 3, 2012 updated by: Konica Minolta Medical Imaging, USA

A Multi-Center Clinical Study to Acquire Xpress Digital Mammography System Images for Computer Aided Detection Development

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

597

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
    • Connecticut
      • Waterbury, Connecticut, United States
        • Waterbury Hospital
    • Florida
      • Miami, Florida, United States
        • Jackson Memorial Hospital
    • Iowa
      • Iowa City, Iowa, United States
        • University of Iowa
    • South Carolina
      • Greenville, South Carolina, United States
        • Greenville Hospital Systems
    • Texas
      • San Antonio, Texas, United States
        • University of Texas San Antonio

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

To achieve the goal of 107 cases with biopsy-proven cancer, it is expected that approximatley 720 patients undergoing breast biopsy will need to be enrolled in the study. In addition, we will enroll up to 330 patients from a screening population.

Description

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

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

Cohorts and Interventions

Group / Cohort
Screening Patients
Female patients scheduled for routine annual screening mammograms
Biopsy Patients
Female patients scheduled for routine breast biopsy procedures

Collaborators and Investigators

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

Sponsor

Konica Minolta Medical Imaging, USA

Investigators

  • Principal Investigator: Etta Pisano, MD, Medical University of South Carolina

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

February 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

December 4, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #03

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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