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Survey of Optical Values of the Breast Using Radiation-Free Pressure-Free Optical Scanning

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.
ClinicalTrials.gov Identifier: NCT00671385
Recruitment Status : Unknown
Verified January 2011 by Spectros Corporation.
Recruitment status was:  Recruiting
First Posted : May 5, 2008
Last Update Posted : February 1, 2011
Information provided by:

Study Description
Brief Summary:
The purposes of this study is to establish normal optical values of breast tissue in the general population. This will allow for establishing normals for breast composition, and is expected to be useful in the classification of breast lesions into groups such as cysts, benign growths, inflammatory lesions, and possibly early breast cancer.

Condition or disease
Breast Lesions Breast Cyst Early-Stage Breast Cancer Benign Growth, Breast

Study Design

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Screening of Breast Cancer Using Radiation-Free Pressure-Free Optical Scanning
Study Start Date : April 2008
Estimated Primary Completion Date : April 2009
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Women 21-50 years old
Women without a diagnosis of cancer or a history of cancer.

Outcome Measures

Primary Outcome Measures :
  1. Optical normals for the breast for a variety of conditions [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Diagnostic compositional standards for (a) diagnosis of a condition such as cyst, benign growth, inflammation, and/or (b) referral for additional evaluation of a region of interest. [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women 18-50 with who EITHER (a) have a region of interest but without a diagnosis, or (b) are healthy volunteers without breast cancer.

Inclusion Criteria:

  • You must be female

    • You must be 21 to 50 years old
    • You must not have or have had breast cancer.
    • You must not have or have had breast implants or breast surgery
    • You must not have had a breast biopsy or injury, or a breast infection, in 90 days.

Exclusion Criteria:

  • Any one or more of the above conditions not met
  • Lack of informed consent
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): NCT00671385

Contact: Lizzy van Thillo, AA 650-851-4040 ext 549 lizzy@spectros.com
Contact: Carrie Bomarito, RN 650-851-4040 ext 0 info@spectros.com

United States, California
Spectros Corporation Recruiting
Portola Valley, California, United States, 94029
Contact: Lizzy van Thillo, AA    650-851-4040 ext 549    lizzy@spectros.com   
Contact: Carrie Bomarito, RN    640-851-4040 ext 0    info@spectros.com   
Sponsors and Collaborators
Spectros Corporation
Stanford University
University of California
Palo Alto Medical Foundation
Study Director: David A Benaron, MD Spectros Corporation
More Information

Responsible Party: Clinical Studies Manager, Spectros Corporation
ClinicalTrials.gov Identifier: NCT00671385     History of Changes
Other Study ID Numbers: BCA-003
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: February 1, 2011
Last Verified: January 2011

Keywords provided by Spectros Corporation:
compositional analysis
breast cyst
breast infection
breast inflammation
benign growth
Women without a diagnosis for a region of interest in the breast

Additional relevant MeSH terms:
Breast Neoplasms
Breast Cyst
Neoplasms by Site
Breast Diseases
Skin Diseases