Breast CancerNCT00540852
Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy
A study testing Diffuse Optical Spectroscopy Imaging in people with Breast Cancer, run by University of California, Irvine at 2 sites in United States.
Trial summary
Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diffuse Optical Spectroscopy Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2002to Jan 2011
- Phase
- Interventional
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old
- Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy
Who cannot join
- Female pregnant and age less than 21 years old and have no diagnosis of breast cancer
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beckman Laser Institute University Of California Irvine
Irvine, California, 92612
Chao Family Comprehensive Cancer Center
Orange, California, 92868
About this study
Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.
Read the detailed description
The Researcher developed a diagnostic device called Diffuse Optical Spectroscopy Imaging is a non-invasive optical technique that utilizes intensity-modulated, near-infrared light to quantitatively measure optical properties in thick tissues.
Diffuse Optical Spectroscopy Imaging can images tissue hemoglobin , oxygen saturation, blood volume fraction, water content, fat content and cellular structure. The measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development.
There is no therapeutic benefit to the subject, especially none that might influence the indication for the diagnostic procedure as indicated. However, information obtained may lead to a new form of non-invasive imaging for the early detection of breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Diffuse Optical Spectroscopy Imaging
- Keywords
- Breast cancer receiving chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse Optical Spectroscopy ImagingDevice
Diffuse Optical Spectroscopy Imaging
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Tool | Other | Diffuse Optical Spectroscopy Imaging Receives: Device: Diffuse Optical Spectroscopy Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic tool
Diffuse Optical Spectroscopy Imaging Breast Cancer Tumor in the response of Chemotherapy
Measured: 12 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 startJun 2002
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 77 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, Chao Family Comprehensive Cancer Center
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- David Hsiang, M.D, Principal investigator, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540852
- Sponsor's protocol ID
- 20022306
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2007
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy
- ClinicalTrials.gov ID
- NCT00540852
- Acronym / sponsor ID
- 20022306
- Conditions
- Breast Cancer
- Keywords
- Breast cancer receiving chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine, Chao Family Comprehensive Cancer Center
- Study start
- Jun 2002
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (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.
Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.
Detailed description
The Researcher developed a diagnostic device called Diffuse Optical Spectroscopy Imaging is a non-invasive optical technique that utilizes intensity-modulated, near-infrared light to quantitatively measure optical properties in thick tissues.
Diffuse Optical Spectroscopy Imaging can images tissue hemoglobin , oxygen saturation, blood volume fraction, water content, fat content and cellular structure. The measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development.
There is no therapeutic benefit to the subject, especially none that might influence the indication for the diagnostic procedure as indicated. However, information obtained may lead to a new form of non-invasive imaging for the early detection of breast cancer.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Tool | Other | Device: Diffuse Optical Spectroscopy ImagingDiffuse Optical Spectroscopy Imaging |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old
- Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy
Key exclusion criteria (1 listed)
- Female pregnant and age less than 21 years old and have no diagnosis of breast cancer
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 Spectroscopy ImagingDiffuse Optical Spectroscopy Imaging | Device | Diagnostic Tool |
Primary outcome
Diagnostic tool
Time frame: 12 weeks
Diffuse Optical Spectroscopy Imaging Breast Cancer Tumor in the response of Chemotherapy
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 1 Nov 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.
David Hsiang, M.D principal investigator
Beckman Laser Institute University of California Irvine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffuse Optical Spectroscopy Imaging in people with Breast Cancer, run by University of California, Irvine at 2 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 2 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: finished, as of the sponsor's last update on 1 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 2 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 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?
Diagnostic tool (time frame: 12 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 1 Nov 2022.