Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System

Not Recruiting

Trial ID: NCT00267449

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

Stanford Investigator(s)

Debra M. Ikeda, M.D.
Debra M. Ikeda, M.D.

Professor of Radiology (Breast Imaging), Emerita

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.

Intervention(s):

device: SoftScan Optical Breast Imaging System

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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