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

NCT00671385 | Unknown DMC

• 3 other identifiers: BCA-003CA126441CA083597
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Optical normals for the breast for a variety of conditions

  3 years

Secondary Outcomes (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.

  1 year

Study Arms (1)

Women 21-50 years old

Women without a diagnosis of cancer or a history of cancer.

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Spectros Corporation: lead
• Stanford University: collaborator
• University of California: collaborator
• Palo Alto Medical Foundation: collaborator

Study Sites (1)

Spectros Corporation

Portola Valley, California, 94029, United States

RECRUITING

MeSH Terms

Conditions

Breast Cyst; Breast Neoplasms; Mastitis; Lipoma

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Site; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Study Officials

• David A Benaron, MD

  Spectros Corporation

  STUDY DIRECTOR

Central Study Contacts

Lizzy van Thillo, AA

CONTACT

650-851-4040; lizzy@spectros.com

Carrie Bomarito, RN

CONTACT

650-851-4040; info@spectros.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 5, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2011
• Last Updated: February 1, 2011

Record last verified: 2011-01

Locations

US (1)