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

This study has suspended participant recruitment.

Sponsor:

Information provided by (Responsible Party):

Charalampaki, Cleopatra, M.D.

ClinicalTrials.gov Identifier:

NCT02491827

First received: July 1, 2015

Last updated: January 30, 2017

Last verified: January 2017

History of Changes

Purpose

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

Condition	Intervention
Cerebral Tumors	Other: Cellvizio mini laser probe


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Biopsy

Genetic and Rare Diseases Information Center resources: Glioma

U.S. FDA Resources

Further study details as provided by Charalampaki, Cleopatra, M.D.:

Primary Outcome Measures:

post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology [ Time Frame: duration of hospital stay, an expected average of 7 days ]

Secondary Outcome Measures:

proof of complete removal of pathologic tissue within healthy tissue [ Time Frame: 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 [ Time Frame: 3 months post surgery ]
Composite measure of missing iatrogenic damage of healthy neuronal structures and preservation of functionality of healthy tissue [ Time Frame: individual post-surgery controls, an expected average of up to 7 days ]


Estimated Enrollment:	60
Study Start Date:	December 2015
Estimated Study Completion Date:	May 2018
Estimated Primary Completion Date:	October 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

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


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

patients suffering from either subcranial Tumors or cerebral gliomata

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02491827

Locations


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

Sponsors and Collaborators

Charalampaki, Cleopatra, M.D.

Investigators


Principal Investigator:	Cleopatra Charalampaki, MD Prof	Department Neurosurgery, Hospital Koeln-Merheim

More Information


Responsible Party:	Charalampaki, Cleopatra, M.D.
ClinicalTrials.gov Identifier:	NCT02491827 History of Changes
Other Study ID Numbers:	CLE 001
Study First Received:	July 1, 2015
Last Updated:	January 30, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Charalampaki, Cleopatra, M.D.:


optical biopsy

ClinicalTrials.gov processed this record on July 14, 2017

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