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

NCT ID: NCT00671385

Last Updated: 2011-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-04-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women 21-50 years old

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

University of California

OTHER

Sponsor Role collaborator

Palo Alto Medical Foundation

OTHER

Sponsor Role collaborator

Spectros Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Spectros Corporation

Principal Investigators

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David A Benaron, MD

Role: STUDY_DIRECTOR

Spectros Corporation

Locations

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Spectros Corporation

Portola Valley, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lizzy van Thillo, AA

Role: CONTACT

650-851-4040 ext. 549

Carrie Bomarito, RN

Role: CONTACT

650-851-4040 ext. 0

Facility Contacts

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Lizzy van Thillo, AA

Role: primary

650-851-4040 ext. 549

Carrie Bomarito, RN

Role: backup

640-851-4040 ext. 0

Other Identifiers

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CA126441

Identifier Type: -

Identifier Source: secondary_id

CA083597

Identifier Type: -

Identifier Source: secondary_id

BCA-003

Identifier Type: -

Identifier Source: org_study_id

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