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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• United States
  • California
    • Portola Valley, California, United States, 94029
      • Recruiting
      • Spectros Corporation
      • Contact: Lizzy van Thillo, AA; Phone Number: 549 650-851-4040; Email: lizzy@spectros.com
      • Contact: Carrie Bomarito, RN; Phone Number: 640-851-4040; Email: info@spectros.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Women 21-50 years old; Women without a diagnosis of cancer or a history of cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Optical normals for the breast for a variety of conditions	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Spectros Corporation
• Collaborators: Stanford University; University of California; Palo Alto Medical Foundation
• Investigators: Study Director: David A Benaron, MD, Spectros Corporation

Publications and helpful links

Helpful Links

• Medical Device Home page

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Anticipated): April 1, 2009
• Study Completion (Anticipated): April 1, 2011

Study Registration Dates

• First Submitted: May 1, 2008
• First Submitted That Met QC Criteria: May 2, 2008
• First Posted (Estimate): May 5, 2008

Study Record Updates

• Last Update Posted (Estimate): February 1, 2011
• Last Update Submitted That Met QC Criteria: January 30, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: breast; screening; metabolism; lipoma; 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: Skin Diseases; Neoplasms; Neoplasms by Site; Cysts; Breast Diseases; Breast Neoplasms; Breast Cyst
• Other Study ID Numbers: BCA-003; CA126441; CA083597