Trial Search Results

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.

Lead Sponsor:

ART Advanced Research Technologies Inc.

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