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

WellSpan Health

Status: Terminated

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00749255

0708052

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

FFDM

Description:

a sum of at least 200 cancer cases, mammographically visible, on at least one image view (including masses and calcifications)