In Vivo Confocal Endomicroscopy of the Brain

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00949793

Enrollment

Registered

2009-07-30

Start date

2008-03-31

Completion date

2009-11-30

Last updated

2009-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms

Keywords

Pathology, Microscopy, Confocal, Microscopy, Fluorescence, Intraoperative Procedures

Brief summary

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.

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.

Interventions

DEVICEEndomicroscope

Endomicroscopic images are taken at several positions on the tumor.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To test of the ability of the surgeon to obtain interpretable images during surgery.	During surgery

Secondary

Measure	Time frame
To correlate the in vivo endomicroscopy images with traditional histopathology.	one week
To evaluate the usability of the device in the OR environment.	During surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026