Accessory; Breast TissueNCT01773551
Development of a Quantitative Tissue Optical Index of Breast Density For Prediction of Hormone Therapy Response
An observational study of Accessory; Breast Tissue, run by University of California, Irvine at 4 sites in United States.
Trial summary
The purpose of this research study is to investigate whether breast density measured by a safe, painless imaging method (called Diffuse Optical Spectroscopic Imaging - DOSI) can detect the decrease of breast density in subjects who receive tamoxifen when compared to patients who do not receive any drug. 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
- Accessory; Breast Tissue
- What is being tested?
- Breast Density
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2012to Apr 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 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Two groups of subjects will be recruited: 1. Pre-menopausal women who will receive the chemoprevention drug tamoxifen (treated) 2. Pre-menopausal women who will not receive any chemoprevention drug (control)
Who may be able to join
None listed.
Who cannot join
- Had or plan to receive any chemotherapy;
- Have bilateral breast cancer
- Previous treatment (chemotherapy, radiation, or surgery) to both breasts, including hormone therapy;
- Are pregnant or nursing;
- Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants;
- Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities;
Show all 9Show fewer
- Have received orthodontic work involving ferromagnetic materials;
- Are claustrophobic; or
- Medically unstable.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pacific Breast Care Medical Clinic
Costa Mesa, California, 92627
Beckman Laser Institute Medical Clinic
Irvine, California, 92612
Chao Family Comprehensive Cancer Center
Orange, California, 92868
Helen Diller Family Comprehensive Cancer Center/ UCSF
San Francisco, California, 94143
About this study
Official title: Development of a Quantitative Tissue Optical Index of Breast Density
The purpose of this research study is to investigate whether breast density measured by a safe, painless imaging method (called Diffuse Optical Spectroscopic Imaging - DOSI) can detect the decrease of breast density in subjects who receive tamoxifen when compared to patients who do not receive any drug. If decreased density can be reliably detected, it may help determine which subjects will benefit by taking tamoxifen or other chemoprevention drugs.
Read the detailed description
The goal of this study is to develop a safe, painless imaging method to measure the change in breast density caused by hormonal chemotherapy treatments such as tamoxifen. For many patients with breast cancer, chemoprevention drugs (such as tamoxifen) can reduce the risk of recurrence. However, tamoxifen can also cause serious side effects such as blood clots and an increased risk of uterine cancer. Patients would benefit from an individualized method of determining whether the chemoprevention is working. Recent studies have shown that a course of tamoxifen is more effective at reducing risk in women who exhibit >10% reduction in breast density compared to women who had little or no density change. The study suggests that breast density is a predictor of the effectiveness of tamoxifen. We propose to use an imaging method that uses safe visible and near-infrared light to measure breast tissue called diffuse optical spectroscopic imaging. Diffuse optical spectroscopic imaging allows patients to be followed through treatment with a cost-effective, bedside, handheld scanning probe. In this study, we will examine whether diffuse optical spectroscopic imaging is sensitive to the density changes induced by tamoxifen as a preventative hormonal chemotherapy agent. MRI will be used as the standard for comparison. We expect to discover that after 12-18 months, women on tamoxifen treatment will show a significant reduction in breast density compared to women not taking tamoxifen, and this change can be monitored using DOSI alone. If validated, our method could be used to determine if tamoxifen treatment is working in an individual patient and could guide doctors about the decision to end and/or switch to a different treatment. In addition, a validated index of density that can be obtained using an inexpensive, risk-free bedside technology could be applied to the challenging problem of measuring individual risk of breast cancer in the broader population.
- Conditions
- Accessory; Breast Tissue
- Being tested
- Breast Density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast DensityOther
Development of a Quantitative Tissue Optical Index of Breast Density
| Study group | Role | What they receive |
|---|---|---|
| Optical Index of Breast Density | Breast Density Receives: Other: Breast Density |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Density
Breast Density
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: Not NIH defined 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-control
- 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 Francisco, Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Thomas O' Sullivan, PhD, Principal investigator, Beckman Laser Institute, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773551
- Sponsor's protocol ID
- 20128714
- Status last verified
- Oct 2022
- First submitted
- 14 Jan 2013
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Quantitative Tissue Optical Index of Breast Density
- ClinicalTrials.gov ID
- NCT01773551
- Acronym / sponsor ID
- 20128714
- Conditions
- Accessory; Breast Tissue
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not NIH defined clinical trial study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Beckman Laser Institute University of California Irvine
- Study start
- Apr 2012
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 23 Jan 2013 (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 research study is to investigate whether breast density measured by a safe, painless imaging method (called Diffuse Optical Spectroscopic Imaging - DOSI) can detect the decrease of breast density in subjects who receive tamoxifen when compared to patients who do not receive any drug. If decreased density can be reliably detected, it may help determine which subjects will benefit by taking tamoxifen or other chemoprevention drugs.
Detailed description
The goal of this study is to develop a safe, painless imaging method to measure the change in breast density caused by hormonal chemotherapy treatments such as tamoxifen. For many patients with breast cancer, chemoprevention drugs (such as tamoxifen) can reduce the risk of recurrence. However, tamoxifen can also cause serious side effects such as blood clots and an increased risk of uterine cancer. Patients would benefit from an individualized method of determining whether the chemoprevention is working. Recent studies have shown that a course of tamoxifen is more effective at reducing risk in women who exhibit >10% reduction in breast density compared to women who had little or no density change. The study suggests that breast density is a predictor of the effectiveness of tamoxifen. We propose to use an imaging method that uses safe visible and near-infrared light to measure breast tissue called diffuse optical spectroscopic imaging. Diffuse optical spectroscopic imaging allows patients to be followed through treatment with a cost-effective, bedside, handheld scanning probe. In this study, we will examine whether diffuse optical spectroscopic imaging is sensitive to the density changes induced by tamoxifen as a preventative hormonal chemotherapy agent. MRI will be used as the standard for comparison. We expect to discover that after 12-18 months, women on tamoxifen treatment will show a significant reduction in breast density compared to women not taking tamoxifen, and this change can be monitored using DOSI alone. If validated, our method could be used to determine if tamoxifen treatment is working in an individual patient and could guide doctors about the decision to end and/or switch to a different treatment. In addition, a validated index of density that can be obtained using an inexpensive, risk-free bedside technology could be applied to the challenging problem of measuring individual risk of breast cancer in the broader population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optical Index of Breast Density | – | Other: Breast DensityBreast Density |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Two groups of subjects will be recruited: 1. Pre-menopausal women who will receive the chemoprevention drug tamoxifen (treated) 2. Pre-menopausal women who will not receive any chemoprevention drug (control)
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Had or plan to receive any chemotherapy;
- Have bilateral breast cancer
- Previous treatment (chemotherapy, radiation, or surgery) to both breasts, including hormone therapy;
- Are pregnant or nursing;
- Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants;
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 |
|---|---|---|
| Breast DensityDevelopment of a Quantitative Tissue Optical Index of Breast Density | Other | Optical Index of Breast Density |
Primary outcome
Breast Density
Time frame: up to 18 months
Breast Density
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 2 Nov 2022.
Related trials for Accessory; Breast Tissue
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
A Study of Radiation Therapy to Treat Solid Tumor Cancer That Has Spread to Soft Tissue
Invasive Ductal Breast Carcinoma, Invasive Ductal Breast Carcinoma Stage IV
Not yet recruiting
The Comparison Between M-E-BCS and C-O-BCS.
Breast Cancer
RecruitingObservational study
Sensitivity of Organoids to Predict Treatment Outcome in Breast Cancer Metastases
Breast Neoplasms
Active, not recruiting
Lifestyles and Breast Cancer
Malignant Tumor of Breast
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.
Thomas O' Sullivan, PhD principal investigator
Beckman Laser Institute, UCI
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 0 inclusion and 9 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 2 Nov 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?
Breast Density (time frame: up to 18 months). 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 2 Nov 2022.