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

Cerebral Tumors Clinical Trial

— Cleopatra  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02491827
• Other study ID #: CLE 001
• Status: Terminated
• Start date: December 2015
• Est. completion date: August 3, 2016

Study information

• Verified date: February 2019
• Source: Charalampaki, Cleopatra, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: August 3, 2016
• Est. primary completion date: August 3, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Tumors

Intervention

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

Locations

Country	Name	City	State
Germany	Clinic of Neurosurgery, Hospital of Cologne	Cologne-Merheim	North Rhine Westfalia

Sponsors (1)

Lead Sponsor	Collaborator
Charalampaki, Cleopatra, M.D.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology		duration of hospital stay, an expected average of 7 days
Secondary	proof of complete removal of pathologic tissue within healthy tissue		during surgical procedure, an expected average time of three hours
Secondary	optimal tumour remission or reduction after 3 months post-surgery proven by respective diagnostic measurements		3 months post surgery
Secondary	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