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Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System

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ClinicalTrials.gov Identifier: NCT00267449
Recruitment Status : Unknown
Verified September 2007 by ART Advanced Research Technologies Inc..
Recruitment status was:  Recruiting
First Posted : December 21, 2005
Last Update Posted : September 11, 2007
Sponsor:
Information provided by:
ART Advanced Research Technologies Inc.

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.

Condition or disease Intervention/treatment
Breast Cancer Device: SoftScan Optical Breast Imaging System

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.

Study Type : Observational
Estimated Enrollment : 950 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
Study Start Date : November 2005

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267449


Contacts
Contact: Margaret Polyzos (514) 832-0777 ext 267 mpolyzos@art.ca

Locations
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
Sponsors and Collaborators
ART Advanced Research Technologies Inc.
Investigators
Study Director: Joseph G Kozikowski, MD ART Advanced Research Technologies Inc.

Publications:
ClinicalTrials.gov Identifier: NCT00267449     History of Changes
Other Study ID Numbers: SSC-311
First Posted: December 21, 2005    Key Record Dates
Last Update Posted: September 11, 2007
Last Verified: September 2007

Keywords provided by ART Advanced Research Technologies Inc.:
Spectroscopy, Near-Infrared
Mammography
Breast Cancer