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Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by ART Advanced Research Technologies Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
ART Advanced Research Technologies Inc.
ClinicalTrials.gov Identifier:
NCT00267449
First received: December 19, 2005
Last updated: September 10, 2007
Last verified: September 2007
History of Changes
  Purpose

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 3

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ART Advanced Research Technologies Inc.:

Estimated Enrollment: 950
Study Start Date: November 2005
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

Ages Eligible for Study:   20 Years to 80 Years
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00267449     History of Changes
Other Study ID Numbers: SSC-311
Study First Received: December 19, 2005
Last Updated: September 10, 2007
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013