Breast LesionsNCT00671385
Survey of Optical Values of the Breast Using Radiation-Free Pressure-Free Optical Scanning
An observational study of Breast Lesions and Breast Cyst, run by Spectros Corporation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Lesions, Breast Cyst, Early-Stage Breast Cancer
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Any one or more of the above conditions not met
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Spectros Corporation
Portola Valley, California, 94029
Lizzy van Thillo, AA, 650-851-4040 ext. 549, lizzy@spectros.com
Carrie Bomarito, RN, 640-851-4040 ext. 0, info@spectros.com
About this study
Official title: 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.
- 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
- Medical subject headings
- Breast Cyst, Breast Neoplasms, Mastitis, Lipoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women 21-50 years old | Women without a diagnosis of cancer or a history of cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optical normals for the breast for a variety of conditions
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spectros Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University, University of California, Palo Alto Medical Foundation
- Investigators
- David A Benaron, MD, Study director, Spectros Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671385
- Sponsor's protocol ID
- BCA-003
- Other IDs
- CA126441, CA083597
- Status last verified
- Jan 2011
- First submitted
- 1 May 2008
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Screening of Breast Cancer Using Radiation-Free Pressure-Free Optical Scanning
- ClinicalTrials.gov ID
- NCT00671385
- Acronym / sponsor ID
- BCA-003
- Keywords
- screening, compositional analysis, metabolism, breast, breast cyst, breast infection, breast inflammation, lipoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Spectros CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University, University of California, Palo Alto Medical Foundation
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 5 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women 21-50 years old | – | –Women without a diagnosis of cancer or a history of cancer. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Any one or more of the above conditions not met
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Optical normals for the breast for a variety of conditions
Time frame: 3 years
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Benaron, MD study director
Spectros Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Lesions and Breast Cyst, run by Spectros Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lizzy van Thillo, AA (650-851-4040 ext. 549, lizzy@spectros.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optical normals for the breast for a variety of conditions (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2011.