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

This study is currently recruiting participants.

Verified by Spectros Corporation, May 2008

Sponsors and Collaborators:	Spectros Corporation Stanford University University of California University of Pennsylvania
Information provided by:	Spectros Corporation
ClinicalTrials.gov Identifier:	NCT00671385

Purpose

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
Breast Lesions Breast Cyst Early-Stage Breast Cancer Benign Growth, Breast

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Nuclear Scans

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Early Screening of Breast Cancer Using Radiation-Free Pressure-Free Optical Scanning

Further study details as provided by Spectros Corporation:

Primary Outcome Measures:

Optical normals for the breast for a variety of conditions [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2000
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders 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.

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671385

Contacts

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

Locations

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

University of Pennsylvania

Investigators

Study Director:

David A Benaron, MD

Spectros Corporation

More Information

Medical Device Home page This link exits the ClinicalTrials.gov site

Responsible Party:	Spectros Corporation ( Clinical Studies Manager )
Study ID Numbers:	SPE-BCA-003, CA126441, CA083597
Study First Received:	May 1, 2008
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00671385
Health Authority:	United States: Institutional Review Board

Keywords provided by Spectros Corporation:

screening
compositional analysis
metabolism
breast
breast cyst

breast infection
breast inflammation
lipoma
benign growth
Women without a diagnosis for a region of interest in the breast

Study placed in the following topic categories:

Breast Cyst
Skin Diseases
Lipoma
Breast Neoplasms

Cysts
Mastitis
Breast Diseases
Inflammation

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009