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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
July 1, 2015
January 30, 2017
December 2015
October 2017   (Final data collection date for primary outcome measure)
post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology [ Time Frame: duration of hospital stay, an expected average of 7 days ]
Same as current
Complete list of historical versions of study NCT02491827 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Confocal Laser Endomicroscopy (CLE) During Medically Induced Neurosurgery in Craniobasal and Glioma Tumours
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
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
patients suffering from either subcranial Tumors or cerebral gliomata
Cerebral 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
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
Intervention: Other: Cellvizio mini laser probe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
60
May 2018
October 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT02491827
CLE 001
No
Not Provided
Plan to Share IPD: No
Charalampaki, Cleopatra, M.D.
Charalampaki, Cleopatra, M.D.
Not Provided
Principal Investigator: Cleopatra Charalampaki, MD Prof Department Neurosurgery, Hospital Koeln-Merheim
Charalampaki, Cleopatra, M.D.
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP