Brain TumorMINCT00555711
Monitoring Neural Tissues Properties by Modulated Imaging (MI)
An observational study of Brain Tumor, run by University of California, Irvine at 2 sites in United States.
Trial summary
We have developed a safe, non-contact, intra-operative guidance system to optimize tumor resection in neurosurgery. The Modulated Imaging is non-contact optical imaging technology developed at the Beckman Laser Institute, UCI. Read more about this study
- Who is it for?
- Ages 1 minute and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Modulated Imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2008to Jan 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 1 minute and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: primary care clinic
Who may be able to join
- All nervous system tumor patients who undergo a preoperative MRI,and undergoing central nervous system operative procedures for non tumor.
Who cannot join
- All emergency neurosurgical procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beckman Laser Institute,University of California,Irvine
Irvine, California, 92612
Neurosurgery department,University of California,Irvine
Orange, California, 92868
About this study
We have developed a safe, non-contact, intra-operative guidance system to optimize tumor resection in neurosurgery. The Modulated Imaging is non-contact optical imaging technology developed at the Beckman Laser Institute, UCI.
Compared to other imaging approaches, MI has the unique capability of performing both diffuse optical tomography and rapid, wide-field quantitative mapping of tissue optical properties within a single measurement platform.
Preliminary in vivo studies have shown that brain tumors, infiltrating tumor margins and normal brain may have intrinsically different optical properties.
Read the detailed description
While compatible with time-modulation methods, MI alternatively uses spatially-modulated illumination for imaging of tissue constituents.
The Modulated Imaging system consists of
- a light projection system that illuminates the tissue with spatial sinusoid patterns.
- a CCD camera which collects the diffusely reflected light in a non-contact geometry. The wavelength of illumination can be selected by bandpass filtering of a broadband source,or by use of a monochromatic source.
Lastly, tissue fluorescence measurements can be performed by placing a combination of source-blocking and bandpass emission filters in front of the camera.
The diffusely reflected amplitude of the modulated wave carries both optical property (absorption, fluorescence, scattering) and depth information. Specifically, the sampling depth of the spatially-modulated wave is a function of the frequency of illumination and the tissue optical properties.
During neurosurgery when nervous tissue is exposed by the attending neurosurgeon, intraoperative pictures will be taken using the modulated imager by the investigators.
The imaging procedure may delay completion of the surgical case by an estimated 10 to 20 minutes. This is minimal prolongation considering most brain tumor resections take several hours.
The images acquired will be processed after the surgical procedure and will not be available to the surgeon during the operative procedure.
- Conditions
- Brain Tumor
- Being tested
- Modulated Imaging
- Keywords
- Brain tumor
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modulated ImagingDevice
Modulated Imaging
| Study group | Role | What they receive |
|---|---|---|
| Modulated Imaging | Modulated Imaging Receives: Device: Modulated Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Tissue Property
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 posted9 Nov 2007 (estimated)
- Study startNov 2008
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Why it stopped: no subject
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies 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
- Cross-sectional
- Enrolment
- 0 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
- Mark Linskey, MD, Principal investigator, University of California, IrvineBruce J Tromberg, PhD, Principal investigator, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555711
- Sponsor's protocol ID
- 20054775
- Acronym
- MI
- Status last verified
- Oct 2022
- First submitted
- 7 Nov 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 Neural Tissues Properties by Modulated Imaging (MI)
- ClinicalTrials.gov ID
- NCT00555711
- Acronym / sponsor ID
- MI / 20054775
- Conditions
- Brain Tumor
- Keywords
- Brain tumor
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no subject
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Nov 2008
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 9 Nov 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.
We have developed a safe, non-contact, intra-operative guidance system to optimize tumor resection in neurosurgery. The Modulated Imaging is non-contact optical imaging technology developed at the Beckman Laser Institute, UCI.
Compared to other imaging approaches, MI has the unique capability of performing both diffuse optical tomography and rapid, wide-field quantitative mapping of tissue optical properties within a single measurement platform.
Preliminary in vivo studies have shown that brain tumors, infiltrating tumor margins and normal brain may have intrinsically different optical properties.
Detailed description
While compatible with time-modulation methods, MI alternatively uses spatially-modulated illumination for imaging of tissue constituents.
The Modulated Imaging system consists of
- a light projection system that illuminates the tissue with spatial sinusoid patterns.
- a CCD camera which collects the diffusely reflected light in a non-contact geometry. The wavelength of illumination can be selected by bandpass filtering of a broadband source,or by use of a monochromatic source.
Lastly, tissue fluorescence measurements can be performed by placing a combination of source-blocking and bandpass emission filters in front of the camera.
The diffusely reflected amplitude of the modulated wave carries both optical property (absorption, fluorescence, scattering) and depth information. Specifically, the sampling depth of the spatially-modulated wave is a function of the frequency of illumination and the tissue optical properties.
During neurosurgery when nervous tissue is exposed by the attending neurosurgeon, intraoperative pictures will be taken using the modulated imager by the investigators.
The imaging procedure may delay completion of the surgical case by an estimated 10 to 20 minutes. This is minimal prolongation considering most brain tumor resections take several hours.
The images acquired will be processed after the surgical procedure and will not be available to the surgeon during the operative procedure.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modulated Imaging | – | Device: Modulated ImagingModulated Imaging |
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- All nervous system tumor patients who undergo a preoperative MRI,and undergoing central nervous system operative procedures for non tumor.
Key exclusion criteria (1 listed)
- All emergency neurosurgical procedures.
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 |
|---|---|---|
| Modulated ImagingModulated Imaging | Device | Modulated Imaging |
Primary outcome
Brain Tissue Property
Time frame: 12 weeks
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 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.
Mark Linskey, MD principal investigator
University of California, Irvine
Bruce J Tromberg, PhD 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?
An observational study of Brain Tumor, 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 1 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: withdrawn, 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 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 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?
Brain Tissue Property (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 20 Oct 2022.