- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01012154
In Vivo Confocal Microscopy Tumor Atlas Study
Study Overview
Detailed Description
Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. The procedure involves a small endoscope which is placed gently into contact with the tissue, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. It is already in clinical use in the field of gastroenterological endoscopy, and investigational use in laparoscopy, dermatology and gynecology. Further, in recent pilot studies endomicroscopy has also been shown to be feasible in bronchoscopy, robot assisted prostatectomy and neurosurgery.The study will use both endomicroscopy and biopsy to document the histological appearance of a range of neurological tumour types and grades.
In subsequent analysis, the confocal image data and corresponding histology data and images will be used to document reliably observable features in the confocal images that are relevant to histopathology interpretation. Relevant images will be selected and discussed by comparison to frozen or permanent section histology for compilation into an atlas documenting comparison for the tumors seen in the study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Peter Nakaji, MD
- Phone Number: 602-406-4808
Study Locations
-
-
Arizona
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Phoenix, Arizona, United States, 85013
- Recruiting
- Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
-
Principal Investigator:
- Peter Nakaji, MD
-
Sub-Investigator:
- Robert F Spetzler, MD
-
Sub-Investigator:
- Jennifer Eschbacher, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients with neurological pathology requiring surgery in which tumour resection might be evaluated by using biopsy
Exclusion Criteria:
- History of allergy to fluorescein
- Patients on beta-blockers or ACE inhibitors
- Pregnant women
- Inability to give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: All patients
|
Endomicroscopic images and biopsies are taken at several positions on the tumor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Generation of an atlas documenting the comparative features of in vivo microscopy versus traditional histopathology of site-matched biopsies across a range of tumor types and grades.
Time Frame: During surgery
|
During surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Test the ability of an expert neuropathologist to predict the outcome of biopsies based on the confocal images collected in vivo.
Time Frame: One week
|
One week
|
Capture usability and workflow aspects for the confocal device.
Time Frame: During surgery
|
During surgery
|
Collaborators and Investigators
Sponsor
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 (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 002874
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.
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