- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00949793
In Vivo Confocal Endomicroscopy of the Brain
The purpose of the study is to test the feasibility of obtaining interpretable in vivo endomicroscopy images which can be compared with traditional histopathology.
Hypothesis: That a rigid confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables differentiation of tumour tissue from normal adjacent brain tissue.
Study Overview
Detailed Description
Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. It is already in clinical use in the fields of gastroenterological endoscopy, laparoscopy, dermatology, gynecology and respiratory medicine. This study represents the first time that confocal endomicroscopy will be evaluated for intraoperative imaging in neurosurgery.
The procedure involves a small endoscope which is placed gently into contact with the brain, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. The captured confocal images will be compared with corresponding histology (tissue that is being removed as part of the indicated neurosurgical procedure). The images will be visually compared among each other and with histology images to detect possible clinically relevant information.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85013
- Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients with neurosurgical pathology requiring surgery in which tumor resection might be evaluated by using biopsy.
Exclusion Criteria:
- Pregnant women
- Inability to give informed consent
- History of allergy to fluorescein
- Patients on beta-blockers or ACE inhibitors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: All patients
|
Endomicroscopic images are taken at several positions on the tumor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To test of the ability of the surgeon to obtain interpretable images during surgery.
Time Frame: During surgery
|
During surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To correlate the in vivo endomicroscopy images with traditional histopathology.
Time Frame: one week
|
one week
|
To evaluate the usability of the device in the OR environment.
Time Frame: During surgery
|
During surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
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
- 002441
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 Neoplasms
-
Constantinos HadjipanayisNational Cancer Institute (NCI); NX PharmaGenWithdrawnGlioblastoma | Brain Cancer | Brain Tumors | Brain Tumor, Recurrent | Benign Neoplasms, Brain | Brain Neoplasms, Benign | Brain Neoplasms, Malignant | Brain Tumor, Primary | Intracranial Neoplasms | Neoplasms, Brain | Neoplasms, Intracranial | Primary Brain Neoplasms | Primary Malignant Brain Neoplasms | Primary Malignant... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedBrain Cancer | Brain Neoplasm | Brain Tumor, PrimaryUnited States
-
Vanderbilt University Medical CenterUniversity of Alabama at Birmingham; Emory University; H. Lee Moffitt Cancer... and other collaboratorsTerminatedBrain Neoplasms, Benign | Brain Neoplasms, Malignant | Brain Neoplasm, PrimaryUnited States
-
BioNumerik Pharmaceuticals, Inc.Crown BioscienceCompletedBrain Neoplasms | Brain Tumors | Malignant Neoplasms, BrainUnited States
-
National Cancer Institute (NCI)TerminatedCentral Nervous System Neoplasms | Brain Cancer | Neoplasms, Brain | Primary Brain Neoplasms | Cancer of the BrainUnited States
-
University of Erlangen-Nürnberg Medical SchoolNot yet recruitingBrain Tumor, Primary | Brain Tumor - MetastaticGermany
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedBrain Stem Neoplasms, Primary | Neoplasms, Brain StemUnited States
-
University of NebraskaRecruitingPrimary Brain Tumor | Metastatic Brain TumorUnited States
-
Mayo ClinicRecruitingBrain Tumor | Brain Tumor Adult | Brain LesionUnited States
-
medac GmbHCompletedBrain Cancer | Brain Tumors | Brain Tumor, Primary | Primary Brain Tumors | Cancer of Brain
Clinical Trials on Endomicroscope
-
Massachusetts General HospitalBill and Melinda Gates Foundation; Aga Khan University Hospital, PakistanEnrolling by invitationEnvironmental Enteric DysfunctionPakistan
-
Carl Zeiss Surgical GmbHUnknown
-
Johannes Gutenberg University MainzCompletedCancer | Ulcerative Colitis | Intraepithelial NeoplasiaGermany
-
Shandong UniversityCompletedIntestinal MetaplasiaChina
-
Shandong UniversityCompletedStomach Neoplasms | Precancerous ConditionsChina
-
Medical University of ViennaCompleted
-
Medical University of ViennaUnknown
-
PENTAX Europe GmbHJohannes Gutenberg University MainzTerminated
-
University of LiegeCompletedPleural CarcinomatosisBelgium
-
University of MichiganTerminatedAdenomatous Polyps | Irritable Bowel Disease | Colonic DysplasiaUnited States