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

BRAINSGATE LTD0 个研究点目标入组 30 人开始时间: 2006年3月15日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-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

•- 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.

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