Confocal Laser Endomicroscopy (CLE) During Medically Induced Neurosurgery in Craniobasal and Glioma Tumours

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-08-03

Brief Summary

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Purpose of the study is to answer the question whether confocal laser endomicroscopy (CLE, also named 'optical biopsy') might improve the results of medically necessary neurosurgery to prove practicability, safety and harmlessness of CLE during neurosurgical procedures

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Detailed Description

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In patients requiring neurosurgical oncological Intervention using endoscopic devices, a mini laser probe will be administered through the endoscopic device to characterize in vivo the tissue by thousandfold magnification down to the cellular level (so-called optical biopsy). Magnification is presented to the neurosurgeon in time to better differentiate between healthy and pathological tissue. Post-surgery results of in-vivo Differentiation will then be compared to histocytopathological findings.

Conditions

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Cerebral Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cellvizio mini laser probe

Cellvizio mini laser probe will be administered via the endoscopic device used for the neurosurgical procedure to provide confocal laser endomicroscopy in patients requiring neurosurgery due to glioma multiforme or subcranial tumors

Cellvizio mini laser probe

Intervention Type OTHER

Cellvizio mini laser probe is administered via the endoscopic device used during the neurosurgical procedures to provide the optical biopsy

Interventions

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Cellvizio mini laser probe

Cellvizio mini laser probe is administered via the endoscopic device used during the neurosurgical procedures to provide the optical biopsy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients administered to the department of neurosurgery requiring neurosurgery due to either diagnosed gliomata (40 patients) or diagnosed subcranial tumors adjacent to or already invading neuronal structures (20 patients)
* patients having given informed consent

Exclusion Criteria

* severe concomitant diseases probably negatively influencing the participation in this clinical trial
* cardial infarction or stroke within the preceding 12 months
* Treatment resistant hypertonus (systolic blood pressure \>200 mmHg or diastolic blood pressure \>120 mmHg or a combination of both
* Pulmonic diseases that might result in an advanced risk for anesthetic measurements
* Patients being vaccinated with live vaccines (14 days Prior) or contra Influenza (7 days Prior) to start of the study
* All concomitant findings that might increase in the eyes of the investigator the risk of participation

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No