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Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System


Phase 3
20 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

Joseph G Kozikowski, MD

Investigator Role:

Study Director

Investigator Affiliation:

ART Advanced Research Technologies Inc.

Authority:

Canada: Health Canada

Study ID:

SSC-311

NCT ID:

NCT00267449

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • Spectroscopy, Near-Infrared
  • Mammography
  • Breast Cancer
  • Breast Neoplasms

Name

Location

University of California-San Diego - Rebecca and John Moores Cancer CenterLa Jolla, California  92093
Stanford University - Stanford Breast Imaging CenterStanford, California  94305
Martin Memorial Health Systems, Stuart - Robert & Carol Weissman Cancer CenterStuart, Florida  34994