Spots Global Cancer Trial Database for Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
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Trial Identification
Brief Title: Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
Official Title: Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
Study ID: NCT00267449
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
University of California-San Diego - Rebecca and John Moores Cancer Center, La Jolla, California, United States
Stanford University - Stanford Breast Imaging Center, Stanford, California, United States
Martin Memorial Health Systems, Stuart - Robert & Carol Weissman Cancer Center, Stuart, Florida, United States
CAMIS - Central Alberta Medical Imaging Services, Red Deer, Alberta, Canada
University Health Network (UNH) - Princess Margaret Hospital, Toronto, Ontario, Canada
MUHC- McGill University Health Center, Montreal, Quebec, Canada
Contact Details
Name: Joseph G Kozikowski, MD
Affiliation: ART Advanced Research Technologies Inc.
Role: STUDY_DIRECTOR
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