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

• Conditions: Breast Lesions; Breast Cyst; Early-Stage Breast Cancer; Benign Growth, Breast

• Registration Number: NCT00671385
• Lead Sponsor: Spectros Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-01
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-05
• Primary Completion: 2009-04
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-30
• Last Update Posted: 2011-02-01
• Study Completion: 2011-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Optical normals for the breast for a variety of conditions	3 years

Secondary Outcome Measures

Name	Time	Method
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.	1 year

Trial Locations

Locations (1)

Spectros Corporation; 🇺🇸 Portola Valley, California, United States