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

Early-Stage Breast Cancer Clinical Trial

Official title:

Early Screening of Breast Cancer Using Radiation-Free Pressure-Free Optical Scanning

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00671385
• Other study ID #: BCA-003
• Secondary ID: CA126441CA083597
• Status: Unknown status
• Phase: N/A
• First received: May 1, 2008
• Last updated: January 30, 2011
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: January 2011
• Source: Spectros Corporation
• Contact: Lizzy van Thillo, AA
• Phone: 650-851-4040
• Email: lizzy[@]spectros.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 2000
• Est. completion date: April 2011
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Spectros Corporation	Portola Valley	California

Sponsors (4)

Lead Sponsor	Collaborator
Spectros Corporation	Palo Alto Medical Foundation, Stanford University, University of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optical normals for the breast for a variety of conditions		3 years
Secondary	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