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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 7, 2007 | ||||||||
| Last Updated Date | March 13, 2009 | ||||||||
| Start Date ICMJE | November 2008 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00555711 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Monitoring Neural Tissues Properties by Modulated Imaging (MI) | ||||||||
| Official Title ICMJE | Monitoring Neural Tissues Properties by Modulated Imaging (MI) | ||||||||
| Brief Summary | We have developed a safe, non-contact, intra-operative guidance system to optimize tumor resection in neurosurgery. The Modulated Imaging (MI) 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. |
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| Detailed Description | While compatible with time-modulation methods, MI alternatively uses spatially-modulated illumination for imaging of tissue constituents. The MI system consists of
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 (MI) 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case-Only, Cross-Sectional | ||||||||
| Condition ICMJE | Brain Tumor | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||
| Estimated Enrollment ICMJE | 70 | ||||||||
| Estimated Completion Date | July 2012 | ||||||||
| Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00555711 | ||||||||
| Responsible Party | Mark Linskey, MD, Beckman Laser Institute | ||||||||
| Study ID Numbers ICMJE | LAMMP WIFI RR-01192-29 | ||||||||
| Study Sponsor ICMJE | University of California, Irvine | ||||||||
| Collaborators ICMJE | Beckman Laser Institute University of California Irvine | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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