Breast CancerNCT01257932
Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging
An observational study of Breast Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
The investigators have developed imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy, both prior to and as early as possible during the course of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diffuse Optical Spectroscopy Imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Oct 2013
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic and community sample
Who may be able to join
- Female, 18 years of age or older, non pregnant or nursing.
- Diagnosis of breast cancer and will be receiving chemo therapy treatments
Who cannot join
- 18 years of age or younger, pregnant or nursing.
- Previous treatment including chemo therapy, radiation, surgery, and hormone therapy.
- Previous diagnosis with other form of cancer.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators have developed imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy, both prior to and as early as possible during the course of treatment.
The efficacy and practicality of conventional imaging approaches in the neoadjuvant chemotherapy setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging is an experimental imaging method that allows patients to be followed from baseline through treatment and surgery with a cost-effective, bedside, handheld scanning probe. The researcher evaluates a harmonized diffuse optical spectroscopic imaging technology platform that has been standardized for neoadjuvant chemotherapy monitoring. Diffuse optical spectroscopic imaging is an academic research platform that is non-invasive. Studies will be performed in five clinical sites on approximately 60 neoadjuvant chemotherapy patients.
Read the detailed description
The investigators are testing the effectiveness of an experimental imaging technology known as Diffuse Optical Spectroscopy Imaging in predicting the success of chemotherapy treatment (shrinkage of tumor).
Diffuse optical spectroscopic imaging measurements are made with a laser breast scanner. This bedside-capable system combines frequency-domain photon migration with steady-state tissue spectroscopy to measure complete(broadband) near-infrared absorption and reduced scattering spectra of breast tissue in vivo. Diffuse Optical Spectroscopy Imaging measurements are made by placing the hand-held probe on the tissue surface and moving the probe to discrete locations along a grid pattern at 1.0 cm intervals. The portable high-bandwidth Frequency-Domain Photon Migration instrument employs intensity-modulated diode lasers and conventional steady-state lamps as sources and an avalanche photodiode as the detector. The time required to perform an Frequency-Domain Photon Migration measurement depends on the desired precision and number of sweeps.
- Conditions
- Breast Cancer
- Being tested
- Diffuse Optical Spectroscopy Imaging
- Keywords
- Breast Cancer
- 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 Breast Cancer Response to Neoadjuvant Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Tool | Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy 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 Breast Cancer Response to Neoadjuvant Chemotherapy
Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: According to the NIH definition of clinical trial studies, this study does not meet requirement to be a clinical trial study.
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
- 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
- American College of Radiology Imaging Network, Massachusetts General Hospital, University of Pennsylvania, Dartmouth-Hitchcock Medical Center, University of San Francisco, M.D. Anderson Cancer Center, Boston University, Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Bruce Tromberg, PhD, Study director, Beckman Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257932
- Sponsor's protocol ID
- 20107812
- Status last verified
- Oct 2022
- First submitted
- 8 Dec 2010
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
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 and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging
- ClinicalTrials.gov ID
- NCT01257932
- Acronym / sponsor ID
- 20107812
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: According to the NIH definition of clinical trial studies, this study does not meet requirement to be a clinical trial study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- American College of Radiology Imaging Network, Massachusetts General Hospital, University of Pennsylvania, Dartmouth-Hitchcock Medical Center, University of San Francisco, M.D. Anderson Cancer Center, Boston University, Beckman Laser Institute University of California Irvine
- Study start
- Dec 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 10 Dec 2010 (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 investigators have developed imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy, both prior to and as early as possible during the course of treatment.
The efficacy and practicality of conventional imaging approaches in the neoadjuvant chemotherapy setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging is an experimental imaging method that allows patients to be followed from baseline through treatment and surgery with a cost-effective, bedside, handheld scanning probe. The researcher evaluates a harmonized diffuse optical spectroscopic imaging technology platform that has been standardized for neoadjuvant chemotherapy monitoring. Diffuse optical spectroscopic imaging is an academic research platform that is non-invasive. Studies will be performed in five clinical sites on approximately 60 neoadjuvant chemotherapy patients.
Detailed description
The investigators are testing the effectiveness of an experimental imaging technology known as Diffuse Optical Spectroscopy Imaging in predicting the success of chemotherapy treatment (shrinkage of tumor).
Diffuse optical spectroscopic imaging measurements are made with a laser breast scanner. This bedside-capable system combines frequency-domain photon migration with steady-state tissue spectroscopy to measure complete(broadband) near-infrared absorption and reduced scattering spectra of breast tissue in vivo. Diffuse Optical Spectroscopy Imaging measurements are made by placing the hand-held probe on the tissue surface and moving the probe to discrete locations along a grid pattern at 1.0 cm intervals. The portable high-bandwidth Frequency-Domain Photon Migration instrument employs intensity-modulated diode lasers and conventional steady-state lamps as sources and an avalanche photodiode as the detector. The time required to perform an Frequency-Domain Photon Migration measurement depends on the desired precision and number of sweeps.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Tool | – | Device: Diffuse Optical Spectroscopy ImagingDiffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic and community sample
Key inclusion criteria (2 listed)
- Female, 18 years of age or older, non pregnant or nursing.
- Diagnosis of breast cancer and will be receiving chemo therapy treatments
Key exclusion criteria (3 listed)
- 18 years of age or younger, pregnant or nursing.
- Previous treatment including chemo therapy, radiation, surgery, and hormone therapy.
- Previous diagnosis with other form of 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 Breast Cancer Response to Neoadjuvant Chemotherapy | Device | Diagnostic Tool |
Primary outcome
Diagnostic Tool Breast Cancer Response to Neoadjuvant Chemotherapy
Time frame: up to 12 months
Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy
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 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.
Bruce Tromberg, PhD study director
Beckman Laser Institute
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 Cancer, 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 3 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 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 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 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?
Diagnostic Tool Breast Cancer Response to Neoadjuvant Chemotherapy (time frame: up to 12 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 1 Nov 2022.