Clinical trial NCT02491827: Confocal Laser Endomicroscopy (CLE) During Medically Induced Neurosurgery in Craniobasal and Glioma Tumours
Official title: Adjoint Intra-operative Confocal Laser Endomicroscopy (CLE) to Present Tissue on the Cellular Level in Defined Lesions of the Central Nervous System (CNS) During Medically Induced Neurosurgery in Subcranial Tumors and Glioma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebral Tumors
Keywords: optical biopsy
Lead sponsor: Charalampaki, Cleopatra, M.D.
Sponsor class: INDIV
First posted: 2015-07-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients suffering from either subcranial Tumors or cerebral gliomata

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.

Eligibility criteria: 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

Primary outcomes:
measure: post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology
timeFrame: duration of hospital stay, an expected average of 7 days
Secondary outcomes:
measure: proof of complete removal of pathologic tissue within healthy tissue
timeFrame: during surgical procedure, an expected average time of three hours
measure: optimal tumour remission or reduction after 3 months post-surgery proven by respective diagnostic measurements
timeFrame: 3 months post surgery
measure: Composite measure of missing iatrogenic damage of healthy neuronal structures and preservation of functionality of healthy tissue
timeFrame: individual post-surgery controls, an expected average of up to 7 days
Other outcomes:
Locations:
city: Cologne-Merheim
country: Germany
facility: Clinic of Neurosurgery, Hospital of Cologne
state: North Rhine Westfalia
Study officials:
affiliation: Department Neurosurgery, Hospital Koeln-Merheim
name: Cleopatra Charalampaki, MD Prof
role: PRINCIPAL_INVESTIGATOR
References: