CClinicalTrials.gg
Status unknownNCT00671385Updated Feb 1, 2011

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

An observational study in Breast Lesions, Breast Cyst and Early-Stage Breast Cancer, sponsored by Spectros Corporation. Status unknown at 1 site in United States. Open to female participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-01.

Sponsored by Spectros Corporation · Observational

The sponsor has not verified this record recently (last verified Jan 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
21 Years to 50 Years
Sex
Female
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Study 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.

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Conditions studied

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

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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
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Spectros Corporation is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
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.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)

Groups and cohorts

  • Women 21-50 years old

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

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What researchers measure

Primary outcomes

  1. Optical normals for the breast for a variety of conditions

    Time frame: 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.

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • Spectros Corporation
    Portola Valley, California 94029, United States
    Recruiting
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00671385
Lead sponsor
Spectros Corporation
Collaborators
Stanford University, University of California, Palo Alto Medical Foundation
First posted
May 5, 2008
Start date
Apr 2008
Primary completion
Apr 2009 (estimated)
Completion
Apr 2011 (estimated)
Last update
Feb 1, 2011

Study contacts

Lizzy van Thillo, AA
Contact
lizzy@spectros.com
650-851-4040 ext. 549
Carrie Bomarito, RN
Contact
info@spectros.com
650-851-4040 ext. 0
David A Benaron, MD
study director · Spectros Corporation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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