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

Charalampaki, Cleopatra, M.D.

Status: Terminated

Conditions: Cerebral Tumors

Treatments: Other: Cellvizio mini laser probe

Study type: Observational

Identifiers

NCT02491827

CLE 001

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Cellvizio mini laser probe

Description:

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

Treatment:

Other: Cellvizio mini laser probe