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Xpress Digital Mammography System Images for Computer Aided Detection Development

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Konica Minolta Medical Imaging, USA
ClinicalTrials.gov Identifier:
NCT01061138
First received: February 1, 2010
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Center Clinical Study to Acquire Xpress Digital Mammography System Images for Computer Aided Detection Development

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Konica Minolta Medical Imaging, USA:

Enrollment: 597
Study Start Date: February 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Screening Patients
Female patients scheduled for routine annual screening mammograms
Biopsy Patients
Female patients scheduled for routine breast biopsy procedures

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061138

Locations
United States, Connecticut
Waterbury Hospital
Waterbury, Connecticut, United States
United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States
United States, Iowa
University of Iowa
Iowa City, Iowa, United States
United States, South Carolina
Greenville Hospital Systems
Greenville, South Carolina, United States
United States, Texas
University of Texas San Antonio
San Antonio, Texas, United States
Sponsors and Collaborators
Konica Minolta Medical Imaging, USA
Investigators
Principal Investigator: Etta Pisano, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Konica Minolta Medical Imaging, USA
ClinicalTrials.gov Identifier: NCT01061138     History of Changes
Other Study ID Numbers: #03
Study First Received: February 1, 2010
Last Updated: December 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Konica Minolta Medical Imaging, USA:
breast cancer
screening mammograms
breast biopsy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013