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Trial record 1 of 2 for:    Open Studies | "Breast Cyst"
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Survey of Optical Values of the Breast Using Radiation-Free Pressure-Free Optical Scanning

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Spectros Corporation.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Stanford University
University of California
Palo Alto Medical Foundation
Information provided by:
Spectros Corporation
ClinicalTrials.gov Identifier:
NCT00671385
First received: May 1, 2008
Last updated: January 30, 2011
Last verified: January 2011
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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
Palo Alto Medical Foundation
Investigators
Study Director: David A Benaron, MD Spectros Corporation
  More Information

No publications provided

Responsible Party: Clinical Studies Manager, Spectros Corporation
ClinicalTrials.gov Identifier: NCT00671385     History of Changes
Other Study ID Numbers: BCA-003, CA126441, CA083597
Study First Received: May 1, 2008
Last Updated: January 30, 2011
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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Cyst
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Cysts

ClinicalTrials.gov processed this record on May 21, 2013