Clinical trial NCT00267449: Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
Official title: Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Spectroscopy, Near-Infrared
Mammography
Breast Cancer
Lead sponsor: ART Advanced Research Technologies Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-21
Enrollment: 950
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California-San Diego - Rebecca and John Moores Cancer Center
state: California
city: Stanford
country: United States
facility: Stanford University - Stanford Breast Imaging Center
state: California
city: Stuart
country: United States
facility: Martin Memorial Health Systems, Stuart - Robert & Carol Weissman Cancer Center
state: Florida
city: Red Deer
country: Canada
facility: CAMIS - Central Alberta Medical Imaging Services
state: Alberta
city: Toronto
country: Canada
facility: University Health Network (UNH) - Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: MUHC- McGill University Health Center
state: Quebec
Study officials:
affiliation: ART Advanced Research Technologies Inc.
name: Joseph G Kozikowski, MD
role: STUDY_DIRECTOR
References:
citation: Intes X. Time-domain optical mammography SoftScan: initial results. Acad Radiol. 2005 Aug;12(8):934-47. doi: 10.1016/j.acra.2005.05.006.