- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00749255
Collect Breast Cancer Patients' Digital Mammography Images With Corresponding Reports for the Development of Software
January 17, 2011 updated by: WellSpan Health
R2 Case Collection
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.
Study Overview
Status
Terminated
Conditions
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
Study Type
Observational
Enrollment (Anticipated)
200
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
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Pennsylvania
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York, Pennsylvania, United States, 17403
- Women's Imaging @ WellSpan Health
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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
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Known breast cancer patients
Description
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 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 |
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FFDM
a sum of at least 200 cancer cases, mammographically visible, on at least one image view (including masses and calcifications)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Misty Hicks, RTRM, Women's Imaging @ WellSpan Health
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
May 1, 2008
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
September 5, 2008
First Submitted That Met QC Criteria
September 8, 2008
First Posted (Estimate)
September 9, 2008
Study Record Updates
Last Update Posted (Estimate)
January 19, 2011
Last Update Submitted That Met QC Criteria
January 17, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0708052
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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