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

Terminated

• Conditions: Cerebral Tumors
• Interventions: Other: Cellvizio mini laser probe

• Registration Number: NCT02491827
• Lead Sponsor: Charalampaki, Cleopatra, M.D.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-03
• Study First Posted: 2015-07-08
• Study Start: 2015-12
• Primary Completion: 2016-08-03
• Study Completion: 2016-08-03
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-05
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cellvizio mini laser probe	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

Primary Outcome Measures

Name	Time	Method
post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology	duration of hospital stay, an expected average of 7 days

Secondary Outcome Measures

Name	Time	Method
proof of complete removal of pathologic tissue within healthy tissue	during surgical procedure, an expected average time of three hours
optimal tumour remission or reduction after 3 months post-surgery proven by respective diagnostic measurements	3 months post surgery
Composite measure of missing iatrogenic damage of healthy neuronal structures and preservation of functionality of healthy tissue	individual post-surgery controls, an expected average of up to 7 days

Trial Locations

Locations (1)

Clinic of Neurosurgery, Hospital of Cologne; 🇩🇪 Cologne-Merheim, North Rhine Westfalia, Germany