Collect Breast Cancer Patients' Digital Mammography Images With Corresponding Reports for the Development of Software

This study has been terminated.
(not enough personnel to conduct study at site)
Sponsor:
Information provided by:
WellSpan Health
ClinicalTrials.gov Identifier:
NCT00749255
First received: September 5, 2008
Last updated: January 17, 2011
Last verified: January 2011
  Purpose

The purpose of this case collection effort is software design by R2 Technologies, Inc., The information received from Women's Imaging will be provided to the Case Collection, Data Management and Algorithm/software design and development teams who are responsible for the receipt of patient data and management of such data; and creation, testing and validation of R2 Technologies, Inc., for Computer Aided Detection (CAD) and new digital image archiving software design.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: R2 Case Collection

Resource links provided by NLM:


Further study details as provided by WellSpan Health:

Estimated Enrollment: 200
Study Start Date: May 2008
Study Completion Date: January 2011
Groups/Cohorts
FFDM
a sum of at least 200 cancer cases, mammographically visible, on at least one image view (including masses and calcifications)

Detailed Description:

The information is necessary for Sponsor development efforts and will be utilized as a viewing tool with supporting written documentation of the findings on each image itself. The information will be used to develop algorithms that will foster development of CAD software. The information in each image and/or accompanying written clinical case documentation will not be analyzed in any way for clinical events

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Known breast cancer patients

Criteria

Inclusion Criteria:

  • subjects with known breast cancer ages 18 and over
  • case images originating from Women's imaging or one of the affiliated screening centers. Raw images must be available for each image
  • source documents or mammographic interpretation must be available

Exclusion Criteria:

  • 17 or younger
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749255

Locations
United States, Pennsylvania
Women's Imaging @ WellSpan Health
York, Pennsylvania, United States, 17403
Sponsors and Collaborators
WellSpan Health
Investigators
Principal Investigator: Misty Hicks, RTRM Women's Imaging @ WellSpan Health
  More Information

No publications provided

Responsible Party: Misty Hicks, RTRM, Women's Imaging
ClinicalTrials.gov Identifier: NCT00749255     History of Changes
Other Study ID Numbers: 0708052
Study First Received: September 5, 2008
Last Updated: January 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by WellSpan Health:
Breast Cancer
Digital archiver software

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

ClinicalTrials.gov processed this record on September 18, 2014