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

Breast Cancer Clinical Trial

Official title:

R2 Case Collection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00749255
• Other study ID #: 0708052
• Status: Terminated
• Phase: N/A
• First received: September 5, 2008
• Last updated: January 17, 2011
• Start date: May 2008
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: WellSpan Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Women's Imaging @ WellSpan Health	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
WellSpan Health

Country where clinical trial is conducted

United States,