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

NCT02491827 | Terminated

• 1 other identifier: CLE 001
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Tumors

Keywords

optical biopsy

Outcome Measures

Primary Outcomes (1)

• post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology

  duration of hospital stay, an expected average of 7 days

Secondary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Cellvizio mini laser probe OTHER

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

Cellvizio mini laser probe

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients suffering from either subcranial Tumors or cerebral gliomata

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charalampaki, Cleopatra, M.D.: lead

Study Sites (1)

Clinic of Neurosurgery, Hospital of Cologne

Cologne-Merheim, North Rhine Westfalia, 51109, Germany

Location

Study Officials

• Cleopatra Charalampaki, MD Prof

  Department Neurosurgery, Hospital Koeln-Merheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 8, 2015
• Study Start: December 1, 2015
• Primary Completion: August 3, 2016
• Study Completion: August 3, 2016
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)