Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
Trial ID or NCT#
NCT00267449
Status
NOT RECRUITING
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
Ages Eligible for Study: 20 Years to 80 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
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.
Investigator(s)
Sanjiv Sam Gambhir, MD, PhD
Contact us to find out if this trial is right for you.
Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
