Status:
UNKNOWN
Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
Lead Sponsor:
ART Advanced Research Technologies Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-80 years
Brief Summary
The primary study endpoint -SoftScan adjunctive accuracy- will be used to test the hypothesis that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy that i...
Detailed Description
Prospective, serially-recruited, blinded and unblinded, validation study to test that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy that is significant...
Eligibility Criteria
Inclusion
- Women between the ages of 20 and 80 years of age, who are either healthy or who are scheduled to undergo a tissue biopsy of surgical excision of a suspicious breast lesion for histopathologic diagnosis.
Exclusion
- For the Healthy Volunteers Population,
- subjects with a history of minor breast procedures involving either breast;
- subjects with a history of major breast procedures involving either breast;
- subjects with a history of significant acute breast abnormalities involving either breast; and
- subjects with a history of significant chronic breast abnormalities involving either breast; and
- For Referred For Biopsy Population,
- subjects with a history of minor breast procedures involving either breast that were performed within 6 months prior to enrollment or which have not completed active healing at the time of enrollment;
- subjects with a history of major breast procedures involving either breast;
- subjects with a history of significant acute breast abnormalities involving either breast which have not completed active healing or resolution within 6 months prior to enrollment; and
- subjects with a history of significant chronic breast abnormalities involving either breast.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
950 Patients enrolled
Trial Details
Trial ID
NCT00267449
Start Date
November 1 2005
Last Update
September 11 2007
Active Locations (6)
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1
University of California-San Diego - Rebecca and John Moores Cancer Center
La Jolla, California, United States, 92093
2
Stanford University - Stanford Breast Imaging Center
Stanford, California, United States, 94305
3
Martin Memorial Health Systems, Stuart - Robert & Carol Weissman Cancer Center
Stuart, Florida, United States, 34994
4
CAMIS - Central Alberta Medical Imaging Services
Red Deer, Alberta, Canada, T4N 4M1