Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
Trial ID or NCT#
Status
Purpose
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.
Official Title
Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
Eligibility 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.
- 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.
Investigator(s)
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Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov