- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00555711
Monitoring Neural Tissues Properties by Modulated Imaging (MI) (MI)
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.
Study Overview
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 Type
Contacts and Locations
Study Locations
-
-
California
-
Irvine, California, United States, 92612
- Beckman Laser Institute,University of California,Irvine
-
Orange, California, United States, 92868
- Neurosurgery department,University of California,Irvine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All nervous system tumor patients who undergo a preoperative MRI,and undergoing central nervous system operative procedures for non tumor.
Exclusion Criteria:
- All emergency neurosurgical procedures.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Modulated Imaging
|
Modulated Imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Brain Tissue Property
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Linskey, MD, University of California, Irvine
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20054775
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Tumor
-
University of California, San FranciscoGilead SciencesSuspendedBrain Cancer | Malignant Brain Tumor | Brain Tumor Adult | Recurrent Brain Tumor | Progressive Malignant Brain Tumor | Brain Tumor, PediatricUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...CNOG-MC001 Collaborative GroupCompletedPediatric Brain Tumor | Malignant Brain Tumor | Tumors, Central Nervous System | Benign Brain TumorChina
-
Technical University of MunichRecruiting
-
University of NebraskaRecruitingPrimary Brain Tumor | Metastatic Brain TumorUnited States
-
University of Erlangen-Nürnberg Medical SchoolNot yet recruitingBrain Tumor, Primary | Brain Tumor - MetastaticGermany
-
GT Medical Technologies, Inc.RecruitingBrain Tumor | Brain Tumor, Recurrent | Brain Tumor, Primary | Brain Tumor - Metastatic | Brain Tumor, Adult: Glioblastoma | Brain Tumor, Adult MeningiomaUnited States
-
Washington University School of MedicineNot yet recruitingBrain Tumor, PrimaryUnited States
-
The Hospital for Sick ChildrenPediatric Oncology Group of OntarioCompletedChildhood Brain TumorCanada
-
Ohio State University Comprehensive Cancer CenterCompletedAdult Brain TumorUnited States
-
Lawson Health Research InstituteCompletedBrain Tumor | Brain Neoplasm | Tumor, Brain | Neoplasm, Supratentorial | Tumor, SupratentorialCanada
Clinical Trials on Modulated Imaging
-
University of California, IrvineBeckman Laser Institute University of California IrvineWithdrawn
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompletedSkin Cancer | Signs and SymptomsUnited States
-
University of California, IrvineNational Institute of General Medical Sciences (NIGMS)RecruitingSkin Burn MultipleUnited States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedMalignant Central Nervous System NeoplasmUnited States
-
Abramson Cancer Center of the University of PennsylvaniaNational Cancer Institute (NCI)CompletedHead and Neck CancerUnited States
-
Abramson Cancer Center of the University of PennsylvaniaCompletedProstate Cancer | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the ProstateUnited States
-
National Cancer Institute (NCI)TerminatedLocally Recurrent Head and Neck Squamous Cell Carcinoma | Nasopharyngeal Squamous Cell Carcinoma | Sinonasal Squamous Cell CarcinomaUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Recurrent Prostate Carcinoma | Metastatic Prostate Adenocarcinoma | Oligometastatic Prostate CarcinomaUnited States
-
University of ViennaRecruitingPain Perception | Autonomic Nervous System FunctioningAustria, Germany
-
National Cancer Institute (NCI)NRG OncologyRecruitingClinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 | Stage III Hypopharyngeal Carcinoma AJCC v8 | Stage III Laryngeal Cancer AJCC v8 | Stage III Lip and Oral Cavity Cancer AJCC v8 | Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 | Stage IVA Lip and Oral... and other conditionsUnited States