|
|
|
|
|
|
Sponsored by: |
ART Advanced Research Technologies Inc. |
Information provided by: | ART Advanced Research Technologies Inc. |
ClinicalTrials.gov Identifier: | NCT00267449 |
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.
Condition | Intervention | Phase |
Breast Cancer |
Device: SoftScan Optical Breast Imaging System |
Phase III |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer Mammography |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
Official Title: | Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System |
Estimated Enrollment: | 950 |
Study Start Date: | November 2005 |
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.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts 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,
For Referred For Biopsy Population,
Contact: Margaret Polyzos | (514) 832-0777 ext 267 | mpolyzos@art.ca |
United States, California | |||||
University of California-San Diego - Rebecca and John Moores Cancer Center | Recruiting | ||||
La Jolla, California, United States, 92093 | |||||
Contact: Denise Darrah 858-657-7027 | |||||
Principal Investigator: Christopher Comstock, M.D. | |||||
Stanford University - Stanford Breast Imaging Center | Recruiting | ||||
Stanford, California, United States, 94305 | |||||
Contact: Leslie Roche 650-724-5913 lesroche@stanford.edu. | |||||
Principal Investigator: Debra M Ikeda, M.D. | |||||
Principal Investigator: Sanjiv S Gambhir, M.D., Ph.D. | |||||
United States, Florida | |||||
Martin Memorial Health Systems, Stuart - Robert & Carol Weissman Cancer Center | Recruiting | ||||
Stuart, Florida, United States, 34994 | |||||
Contact 772-228-5858 | |||||
Principal Investigator: James J Vopal, M.D. | |||||
Canada, Alberta | |||||
CAMIS - Central Alberta Medical Imaging Services | Recruiting | ||||
Red Deer, Alberta, Canada, T4N 4M1 | |||||
Contact 403-343-6172 ext 2259 | |||||
Principal Investigator: Bernice Capusten, MD | |||||
Canada, Ontario | |||||
University Health Network (UNH) - Princess Margaret Hospital | Recruiting | ||||
Toronto, Ontario, Canada, M5G 2M9 | |||||
Contact (416) 946-4501 | |||||
Principal Investigator: Pavel Crystal, M.D. | |||||
Canada, Quebec | |||||
MUHC- McGill University Health Center | Active, not recruiting | ||||
Montreal, Quebec, Canada, H3A 1A1 |
ART Advanced Research Technologies Inc. |
Study Director: | Joseph G Kozikowski, MD | ART Advanced Research Technologies Inc. |
Study ID Numbers: | SSC-311 |
First Received: | December 19, 2005 |
Last Updated: | September 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00267449 |
Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
|
|
|