SoftScan Optical Breast Imaging System in Breast Cancer - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Breast Cancer

Intervention / Treatment

Device: SoftScan Optical Breast Imaging System

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.

Study Type

Observational

Enrollment (Anticipated)

950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Red Deer, Alberta, Canada, T4N 4M1
    - Recruiting
    - CAMIS - Central Alberta Medical Imaging Services
    - Contact:
      
      Phone Number: 2259 403-343-6172
    - Principal Investigator:
      
      Bernice Capusten, MD
- Ontario
  - Toronto, Ontario, Canada, M5G 2M9
    - Recruiting
    - University Health Network (UNH) - Princess Margaret Hospital
    - Contact:
      
      Phone Number: (416) 946-4501
    - Principal Investigator:
      
      Pavel Crystal, M.D.
- Quebec
  - Montreal, Quebec, Canada, H3A 1A1
    - Active, not recruiting
    - MUHC- McGill University Health Center
United States
- California
  - La Jolla, California, United States, 92093
    - Recruiting
    - University of California-San Diego - Rebecca and John Moores Cancer Center
    - Contact:
      
      Denise Darrah
      
      Phone Number: 858-657-7027
    - Principal Investigator:
      
      Christopher Comstock, M.D.
  - Stanford, California, United States, 94305
    - Recruiting
    - Stanford University - Stanford Breast Imaging Center
    - Contact:
      
      Leslie Roche
      
      Phone Number: 650-724-5913
      
      Email: lesroche@stanford.edu.
    - Principal Investigator:
      
      Debra M Ikeda, M.D.
    - Principal Investigator:
      
      Sanjiv S Gambhir, M.D., Ph.D.
- Florida
  - Stuart, Florida, United States, 34994
    - Recruiting
    - Martin Memorial Health Systems, Stuart - Robert & Carol Weissman Cancer Center
    - Contact:
      
      Phone Number: 772-228-5858
    - Principal Investigator:
      
      James J Vopal, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Defined Population
Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Advanced Research Technologies Inc.

Investigators

Study Director: Joseph G Kozikowski, MD, ART Advanced Research Technologies Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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. Erratum In: Acad Radiol. 2005 Oct;12(10):1355.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Registration Dates

First Submitted

December 19, 2005

First Submitted That Met QC Criteria