Accessory; Breast TissueNCT00540540
Measurements of Breast Tissue Optical Properties
An observational study of Accessory; Breast Tissue, run by University of California, Irvine at 4 sites in United States.
Trial summary
Approximately twelve percent of the women in the United States will develop breast cancer, the most common form of cancer affecting women, with 183,000 new cases projected for 1995. Despite the increasing incidence, the age-adjusted death rate from carcinoma has remained relatively stable. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Accessory; Breast Tissue
- What is being tested?
- Diffuse Optical Spectroscopy
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 1995to Jul 2018
- 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 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will be selected from University of California Irvine Medical Clinic and Cancer Center.
Who may be able to join
- Non-pregnant woman age 18 yrs and older.
Who cannot join
- pregnant woman and younger than 18 yrs of age.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pacific Breast Care Medical Clinic
Costa Mesa, California, 92627
Beckman Laser Institute University of California Irvine
Irvine, California, 92612
UCSD Regional Fertility Center
La Jolla San Diego, California, 92037
Chao Family Comprehensive Cancer Center, UCIMC
Orange, California, 92868
About this study
Approximately twelve percent of the women in the United States will develop breast cancer, the most common form of cancer affecting women, with 183,000 new cases projected for 1995. Despite the increasing incidence, the age-adjusted death rate from carcinoma has remained relatively stable. Although the reason for this has not yet been demonstrated, this stability may be a direct consequence of early detection and improved therapy. Screening mammography as an early detection technique has been shown to reduce mortality by 23%. Mammographic abnormalities that go on to biopsy show 24% being positive for malignancy with great variability (6-75%). Breast biopsy is an expensive procedure with the risks of anesthesia and surgery which may be obviated by more specific non-invasive testing.
Read the detailed description
Diffuse Optical Spectroscopic Imaging a new method for quantitative characterization of the optical properties of tissues. The diagnostic tools utilize anomalies in the transmission of diffusing near infra-red light for the rapid detection of oxygenated and deoxygenated hemoglobin, near infra-red absorbing drug levels, blood volume changes, and scattering properties in tissues.
Diffuse Optical Spectroscopic Imaging measurements of breast tissue optical properties probe is similar in shape to an ultrasound probe. The imaging can measurements on different areas of the breast including diseased location and normal area. Optical measurements can guided by co-registered ultrasound measurements for the purpose of determining lesion size and location. Each measurement will require about 5-60 seconds to record the data and calculate optical properties. The process will be repeated until an adequate number of measurements are performed and measurements take 30 to 90 minutes.
The researcher can determine that breast optical properties on demographic information, such as age and menopausal status as well as medical history.
- Conditions
- Accessory; Breast Tissue
- Being tested
- Diffuse Optical Spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse Optical SpectroscopyDevice
Breast properties scanning
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Breast
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startDec 1995
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: According to NIH definition of clinical trial studies, this study does not meet requirement for clinical trial study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accessory; Breast TissueStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Bruce J Tromberg, Ph.D, Principal investigator, Beckman Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540540
- Sponsor's protocol ID
- 1995563
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2007
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Breast Tissue Optical Properties
- ClinicalTrials.gov ID
- NCT00540540
- Acronym / sponsor ID
- 1995563
- Conditions
- Accessory; Breast Tissue
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: According to NIH definition of clinical trial studies, this study does not meet requirement for clinical trial study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of California, San Diego, Beckman Laser Institute University of California Irvine
- Study start
- Dec 1995
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 8 Oct 2007 (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.
Approximately twelve percent of the women in the United States will develop breast cancer, the most common form of cancer affecting women, with 183,000 new cases projected for 1995. Despite the increasing incidence, the age-adjusted death rate from carcinoma has remained relatively stable. Although the reason for this has not yet been demonstrated, this stability may be a direct consequence of early detection and improved therapy. Screening mammography as an early detection technique has been shown to reduce mortality by 23%. Mammographic abnormalities that go on to biopsy show 24% being positive for malignancy with great variability (6-75%). Breast biopsy is an expensive procedure with the risks of anesthesia and surgery which may be obviated by more specific non-invasive testing.
Detailed description
Diffuse Optical Spectroscopic Imaging a new method for quantitative characterization of the optical properties of tissues. The diagnostic tools utilize anomalies in the transmission of diffusing near infra-red light for the rapid detection of oxygenated and deoxygenated hemoglobin, near infra-red absorbing drug levels, blood volume changes, and scattering properties in tissues.
Diffuse Optical Spectroscopic Imaging measurements of breast tissue optical properties probe is similar in shape to an ultrasound probe. The imaging can measurements on different areas of the breast including diseased location and normal area. Optical measurements can guided by co-registered ultrasound measurements for the purpose of determining lesion size and location. Each measurement will require about 5-60 seconds to record the data and calculate optical properties. The process will be repeated until an adequate number of measurements are performed and measurements take 30 to 90 minutes.
The researcher can determine that breast optical properties on demographic information, such as age and menopausal status as well as medical history.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be selected from University of California Irvine Medical Clinic and Cancer Center.
Key inclusion criteria (1 listed)
- Non-pregnant woman age 18 yrs and older.
Key exclusion criteria (1 listed)
- pregnant woman and younger than 18 yrs of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffuse Optical SpectroscopyBreast properties scanning | Device | – |
Primary outcome
Healthy Breast
Time frame: up to 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
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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.
Bruce J Tromberg, Ph.D principal investigator
Beckman Laser Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Accessory; Breast Tissue, run by University of California, Irvine at 4 sites 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Breast (time frame: up to 4 weeks). 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 20 Oct 2022.