Breast Cancer
Conditions
Keywords
Spectroscopy, Near-Infrared, Mammography, Breast Cancer
Brief summary
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.
Detailed description
Prospective, serially-recruited, blinded and unblinded, validation study to test that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy that is significantly better than x-ray mammography alone. Healthy volunteers and patients scheduled for tissue biopsy/excision of a suspicious breast lesion will be enrolled. Reader Studies will be performed in which interpreting investigators will perform blinded mammography interpretations, and reinterpretations of mammography and SoftScan interpretations. Diagnostic accuracy will be calculated using tissue histopathology as the reference standard.
Interventions
DEVICESoftScan Optical Breast Imaging System
Sponsors
ART Advanced Research Technologies Inc.
Study design
Observational model
DEFINED_POPULATION
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
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.
Countries
Canada, United States
Contacts
Primary ContactMargaret Polyzos
Outcome results
None listed