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

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

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

Study Overview

• Status: Terminated
• Conditions: Cerebral Tumors
• Intervention / Treatment: Other: Cellvizio mini laser probe

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 Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Germany
  • North Rhine Westfalia
    • Cologne-Merheim, North Rhine Westfalia, Germany, 51109
      • Clinic of Neurosurgery, Hospital of Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients suffering from either subcranial Tumors or cerebral gliomata

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Charalampaki, Cleopatra, M.D.
• Investigators: Principal Investigator: Cleopatra Charalampaki, MD Prof, Department Neurosurgery, Hospital Koeln-Merheim

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): August 3, 2016
• Study Completion (Actual): August 3, 2016

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 3, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: optical biopsy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: CLE 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No