A multicenter prospective study Safety and feasibility of NeuropathTM Activation during chemiotherapy on Inoperable and Recurrent Glioblastoma Multiforme Patients - ND

Conditions: Recurrent Glioblastoam multiforme
Level: PTClassification code 10018337

Registration Number: EUCTR2005-004138-42-IT

Lead Sponsor: BRAINSGATE LTD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

Inclusion Criteria

-Patient with histologically proven classified glioblastoma multiforme. - Disease Inoperable evidence of inability to surgically remove the tumor size,significant infiltration etc ; - Disease recurrence evidence of tumor growth resistant or recurrence per imaging CT or MRI or PET following prior surgery and radiotherapy. At least 4 weeks has elapsed from the last treatment modality radiotherapy or chemotherapy that the patient has received until the beginning of the second Part of the study PART II . Successfully passing part I of the clinical trial, approval of Radiologist and PI that Gadolinium DTPA has passed the BBB measured by the difference from the baseline enhanced MRI without stimulation and enhanced MRI after stimulation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnancy - Severe cardiac or pulmonary disease. - Severe preexisting motor or sensory neurotoxicity greater than grade 2 NCI criteria . - Serious systemic infection. - Local infection in the operation area. - Coagulopathy preventing the patient from undergoing surgery. - Known sensitivity to Paclitaxel, Gadolinium DTPA or to local or general anesthetic. - Received Paclitaxel treatment in the past - Severe disabling CNS disorder not related to the tumor. - Have other electrical or electromagnetic implantable devices. - Currently participating in any other trials. - Patients that have undergone SPG ablation in the past.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: The secondary objectives are to assess the feasibility of NeuroPath stimulation in improving the bioavailability of Paclitaxel and on the progression of GBM disease in inoperable and recurrent GBM patients measured by MRI or CT. Furthermore to assess Patient survival and measurement of Paclitaxel levels in the plasma and CSF.;Main Objective: The primary objectives of the study are to assess the safety and tolerability of the implantation of the NeuroPath System, and the stimulation of the SPG in patients with glioblastoma multiforme GBM during chemotherapy with Paclitaxel.;Primary end point(s): Assess the safety and tolerability of the device implantation of the NeuroPath System, and the stimulation of the SPG in patients with glioblastoma multiforme GBM during chemotherapy with Paclitaxel.

Secondary Outcome Measures