Breast TumorNCT02725658
Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI
A study testing DOSI in people with Breast Tumor, run by Beckman Laser Institute and Medical Center at 4 sites in United States.
Trial summary
The purpose of this research study is to help us learn if an experimental imaging device called Diffuse Optical Spectroscopic Imaging (DOSI) can monitor tumor shrinkage during chemotherapy treatment and can predict if the tumor will respond to chemotherapy before the end of the treatment. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Tumor
- What is being tested?
- DOSI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2015to Dec 2019
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females between the ages of 21 and 80. Specific to Study part #1
- Diagnosed with a Breast Imaging-Reporting and Data System score of 4 or higher breast abnormality greater than 1cm in size Specific to Study part #2
- Enrolled in study part #1
- Diagnosed with histologically-proven invasive breast cancer
- Prescribed neoadjuvant chemotherapy for breast cancer
Who cannot join
- Pregnant
- Unable to give written, informed consent.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pacific Breast Care Clinic
Costa Mesa, California, 92627
Beckman Laser Institute University of California Irvine
Irvine, California, 92612
University of California, Irvine Medical Center
Irvine, California, 92612
University of California San Francisco
San Francisco, California, 94110
About this study
Official title: Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging in a Multi-Center Setting
The purpose of this research study is to help us learn if an experimental imaging device called Diffuse Optical Spectroscopic Imaging (DOSI) can monitor tumor shrinkage during chemotherapy treatment and can predict if the tumor will respond to chemotherapy before the end of the treatment. This study will also help us understand the biological reason for how DOSI works.
Read the detailed description
There is considerable interest in developing imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy (NAC), which is chemotherapy given before surgical removal of the tumor, both prior to and as early as possible during the course of treatment. The efficacy and practicality of conventional imaging approaches in the NAC setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging (DOSI) is an experimental imaging method that allows patients to be followed before and during treatment with a cost-effective, bedside, handheld scanning probe. DOSI is a non-invasive technology developed at the University of California, Irvine Beckman Laser Institute. Studies will be performed at seven clinical sites on approximately 200 suspected breast cancer patients, of which 150 are expected to undergo neoadjuvant chemotherapy (NAC).
As a primary aim, the investigators will evaluate whether DOSI can predict NAC pathologic complete response (pCR), which is defined as no tumor cell left in the resected tissue at surgery) by the mid-point of the therapy regimen. As non-invasive DOSI is obtained rapidly with no risk/discomfort, this experimental imaging modality could be used as an indicator of pathologic response which has been an established indicator of long-term survival. The investigators long-term goal is to provide oncologists with a relatively simple, risk-free bedside tool that can be used to help inform medical decisions on chemotherapy regimen, duration, and timing of surgery, thereby maximizing therapeutic response and minimizing unnecessary toxicity.
- Conditions
- Breast Tumor
- Being tested
- DOSI
- Keywords
- Neoadjuvant Therapy, Diffuse Optical Spectroscopic Imaging, DOSI, Neoadjuvant 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.
DOSIDevice
Also called Diffuse Optical Spectroscopy
Breast tissue properties scanning
| Study group | Role | What they receive |
|---|---|---|
| DOSI | Other | Not described Receives: Device: DOSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of oxy-hemoglobin (HbO2), in blood.
Measured: through study completion, an average of 3 years
Concentration of deoxy-hemoglobin (HHb) in blood.
Measured: through study completion, an average of 3 years
Concentration of total hemoglobin in blood.
Measured: through study completion, an average of 3 years
Water content of tissue (%)
Measured: through study completion, an average of 3 years
Bulk lipid in tissue (%)
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: This study doesn't meet NIH criteria of 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 TumorStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beckman Laser Institute and Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine, University of California, San Francisco
- Responsible party
- Sponsor-investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Bruce J Tromberg, PhD, Principal investigator, Beckman Laser Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725658
- Sponsor's protocol ID
- 20152355
- Status last verified
- Oct 2022
- First submitted
- 29 Jan 2016
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging in a Multi-Center Setting
- ClinicalTrials.gov ID
- NCT02725658
- Acronym / sponsor ID
- 20152355
- Conditions
- Breast Tumor
- Keywords
- Neoadjuvant Therapy, Diffuse Optical Spectroscopic Imaging, DOSI, Neoadjuvant Chemotherapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study doesn't meet NIH criteria of clinical trial study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beckman Laser Institute and Medical CenterUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine, University of California, San Francisco
- Study start
- Dec 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Apr 2016 (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 help us learn if an experimental imaging device called Diffuse Optical Spectroscopic Imaging (DOSI) can monitor tumor shrinkage during chemotherapy treatment and can predict if the tumor will respond to chemotherapy before the end of the treatment. This study will also help us understand the biological reason for how DOSI works.
Detailed description
There is considerable interest in developing imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy (NAC), which is chemotherapy given before surgical removal of the tumor, both prior to and as early as possible during the course of treatment. The efficacy and practicality of conventional imaging approaches in the NAC setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging (DOSI) is an experimental imaging method that allows patients to be followed before and during treatment with a cost-effective, bedside, handheld scanning probe. DOSI is a non-invasive technology developed at the University of California, Irvine Beckman Laser Institute. Studies will be performed at seven clinical sites on approximately 200 suspected breast cancer patients, of which 150 are expected to undergo neoadjuvant chemotherapy (NAC).
As a primary aim, the investigators will evaluate whether DOSI can predict NAC pathologic complete response (pCR), which is defined as no tumor cell left in the resected tissue at surgery) by the mid-point of the therapy regimen. As non-invasive DOSI is obtained rapidly with no risk/discomfort, this experimental imaging modality could be used as an indicator of pathologic response which has been an established indicator of long-term survival. The investigators long-term goal is to provide oncologists with a relatively simple, risk-free bedside tool that can be used to help inform medical decisions on chemotherapy regimen, duration, and timing of surgery, thereby maximizing therapeutic response and minimizing unnecessary toxicity.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOSI | Other | Device: DOSI |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females between the ages of 21 and 80. Specific to Study part #1
- Diagnosed with a Breast Imaging-Reporting and Data System score of 4 or higher breast abnormality greater than 1cm in size Specific to Study part #2
- Enrolled in study part #1
- Diagnosed with histologically-proven invasive breast cancer
- Prescribed neoadjuvant chemotherapy for breast cancer
Key exclusion criteria (2 listed)
- Pregnant
- Unable to give written, informed consent.
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 |
|---|---|---|
| DOSIAlso: Diffuse Optical SpectroscopyBreast tissue properties scanning | Device | DOSI |
Primary outcome
Concentration of oxy-hemoglobin (HbO2), in blood.
Time frame: through study completion, an average of 3 years
Concentration of deoxy-hemoglobin (HHb) in blood.
Time frame: through study completion, an average of 3 years
Concentration of total hemoglobin in blood.
Time frame: through study completion, an average of 3 years
Water content of tissue (%)
Time frame: through study completion, an average of 3 years
Bulk lipid in tissue (%)
Time frame: through study completion, an average of 3 years
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.
- Individual participant dataSharing planned: No
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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, PhD 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?
A study testing DOSI in people with Breast Tumor, run by Beckman Laser Institute and Medical Center 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 5 inclusion and 2 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 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?
Concentration of oxy-hemoglobin (HbO2), in blood. (time frame: through study completion, an average of 3 years). The study lists 5 primary outcomes in all. 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.