Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
Conditions
Breast Cancer
Conditions: Keywords
Spectroscopy, Near-Infrared, Mammography, Breast Cancer
Study Type
Observational
Study Phase
Phase 3
Study Design
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal
Intervention
Name: SoftScan Optical Breast Imaging System
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Female
Criteria: 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.
Locations
University of California-San Diego - Rebecca and John Moores Cancer Center
La Jolla, California, United States
Status: Recruiting
Contact: Denise Darrah - 858-657-7027
Stanford University - Stanford Breast Imaging Center
Stanford, California, United States
Status: Recruiting
Contact: Leslie Roche - 650-724-5913 - lesroche@stanford.edu.
Martin Memorial Health Systems, Stuart - Robert & Carol Weissman Cancer Center
Stuart, Florida, United States
Status: Recruiting
Contact: - 772-228-5858
CAMIS - Central Alberta Medical Imaging Services
Red Deer, Alberta, Canada
Status: Recruiting
Contact: - 403-343-6172
University Health Network (UNH) - Princess Margaret Hospital
Toronto, Ontario, Canada
Status: Recruiting
Contact: - (416) 946-4501
MUHC- McGill University Health Center
Montreal, Quebec, Canada
Status: Active, not recruiting
Start Date
November 2005
Sponsors
ART Advanced Research Technologies Inc.
Source
ART Advanced Research Technologies Inc.
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page