Education and Training
Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
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 is significantly better than x-ray mammography alone.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- device: SoftScan Optical Breast Imaging System
Eligibility
Inclusion Criteria:
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 Criteria:
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.
Ages Eligible for Study
20 Years - 80 Years
Genders Eligible for Study
Female
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting