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Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by ART Advanced Research Technologies Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00267449
First Posted: December 21, 2005
Last Update Posted: September 11, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ART Advanced Research Technologies Inc.
  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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
Information from the National Library of Medicine

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.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00267449     History of Changes
Other Study ID Numbers: SSC-311
First Submitted: December 19, 2005
First Posted: December 21, 2005
Last Update Posted: September 11, 2007
Last Verified: September 2007

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