Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System

This study is currently recruiting participants.

Verified by ART Advanced Research Technologies Inc., September 2007

Sponsored by:	ART Advanced Research Technologies Inc.
Information provided by:	ART Advanced Research Technologies Inc.
ClinicalTrials.gov Identifier:	NCT00267449

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 III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mammography

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Prospective Study
Official Title:	Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System

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:

Intes X. Time-domain optical mammography SoftScan: initial results. Acad Radiol. 2005 Aug;12(8):934-47.

Study ID Numbers:	SSC-311
Study 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

Keywords provided by ART Advanced Research Technologies Inc.:

Spectroscopy, Near-Infrared
Mammography
Breast Cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009