Accessory; Breast TissueNCT00540306
Monitoring Functional Variation in the Breast During Menstrual Cycle by Using Diffuse Optical Spectroscopy
An observational study of Accessory; Breast Tissue, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this study is to do determine the changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy. Read more about this study
- Who is it for?
- Ages 18 to 40 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
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Oct 2012
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: primary care clinic, community sample
Who may be able to join
- Pre-Menopausal female 18 years of age or older with normal breast tissue
- Undergoes regular menstrual cycle cycles that do not vary by more than 5 days
Who cannot join
- Peri-Menopausal and Post-Menopausal
- Subjects taking oral contraceptives or any birth control medications in the past six months
- Diagnosed with breast cancer or cancer survivor,a history of breast surgery
- Subjects taking light sensitive drugs for photodynamic therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute University of California Irvine
Irvine, California, 92612
About this study
The purpose of this study is to do determine the changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy. The Researcher can determine 1) how large variations in breast tissue components are 2) how predictable and repeatable these variations are 3) the effects of endogenous hormones on breast tissue physiology.
Read the detailed description
Variations in breast physiology due to hormonal fluctuations during the menstrual cycle can correlate to quantitative changes in Diffuse Optical Spectroscopy functional parameters such as hemoglobin, lipid and water concentration and tissue scattering. Diffuse Optical Spectroscopy imaging can show increase blood flow in breast tissue after ovulation with a concomitant increase in mitotic activity, changes in hemoglobin concentration and in tissue scattering. Increases in fibroglandular breast tissue after ovulation have also been observed. Diffuse Optical Spectroscopy imaging can determine after time of ovulation has been detected during the two months of self-monitoring.
- Conditions
- Accessory; Breast Tissue
- Being tested
- Diffuse Optical Spectroscopy
- Keywords
- breast tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse Optical SpectroscopyDevice
Also called Diffuse Optical Spectroscopy Imaging
Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Tool | Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy Receives: Device: Diffuse Optical Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Tissue Physiology
Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle
Measured: 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 startFeb 2006
- Primary completionOct 2012
- Study completionOct 2012
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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- 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 University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540306
- Sponsor's protocol ID
- 20054760
- 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
- Monitoring Functional Variation in the Breast During Menstrual Cycle by Using Diffuse Optical Spectroscopy
- ClinicalTrials.gov ID
- NCT00540306
- Acronym / sponsor ID
- 20054760
- Conditions
- Accessory; Breast Tissue
- Keywords
- breast tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Feb 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- 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.
The purpose of this study is to do determine the changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy. The Researcher can determine 1) how large variations in breast tissue components are 2) how predictable and repeatable these variations are 3) the effects of endogenous hormones on breast tissue physiology.
Detailed description
Variations in breast physiology due to hormonal fluctuations during the menstrual cycle can correlate to quantitative changes in Diffuse Optical Spectroscopy functional parameters such as hemoglobin, lipid and water concentration and tissue scattering. Diffuse Optical Spectroscopy imaging can show increase blood flow in breast tissue after ovulation with a concomitant increase in mitotic activity, changes in hemoglobin concentration and in tissue scattering. Increases in fibroglandular breast tissue after ovulation have also been observed. Diffuse Optical Spectroscopy imaging can determine after time of ovulation has been detected during the two months of self-monitoring.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Tool | – | Device: Diffuse Optical SpectroscopyChanges in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- primary care clinic, community sample
Key inclusion criteria (2 listed)
- Pre-Menopausal female 18 years of age or older with normal breast tissue
- Undergoes regular menstrual cycle cycles that do not vary by more than 5 days
Key exclusion criteria (4 listed)
- Peri-Menopausal and Post-Menopausal
- Subjects taking oral contraceptives or any birth control medications in the past six months
- Diagnosed with breast cancer or cancer survivor,a history of breast surgery
- Subjects taking light sensitive drugs for photodynamic therapy
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 SpectroscopyAlso: Diffuse Optical Spectroscopy ImagingChanges in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle using Diffuse Optical Spectroscopy | Device | Diagnostic Tool |
Primary outcome
Breast Tissue Physiology
Time frame: 4 weeks
Changes in physiological and optical properties in healthy pre-menopausal breast tissue during the menstrual cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 University of California Irvine
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 Accessory; Breast Tissue, run by University of California, Irvine 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 2 inclusion and 4 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: finished, 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Breast Tissue Physiology (time frame: 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.