Performance and Safety of thermotherapy with nanoparticles (NanoTherm® Therapy System) as an adjuvant therapy to the Standard of Care treatment of patients with recurrent glioblastoma
- Conditions
- C71.9Brain, unspecified
- Registration Number
- DRKS00023339
- Lead Sponsor
- MagForce AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 5
Male and female patients with recurrent glioblastoma (first or repeated recurrence)
Age 18-75 Years
Informed Consent in writing
Karnofsky Index = 60
Life expectancy > 6 months
Failed standard therapy (Stupp regiment, TTF)
Stable corticoid requirements = 2mg dexamethasone / d
Known Molecular differentiation (MGMT promoter methylation, IDH mutation status, 1p/19q deletion status)
Cardiopulmonary compliance (heat and lying flat in the field generator for approx. 60 minutes must be tolerated
Psychological resilience
Patients older than 75years
Pregnant or breast-feeding women
> 3 multiple glioblastoma lesions
Speech or motor brain functions in/at resection area
Subependymal contrast enhancement in adjacent ventricles
Simultaneous therapy with immunomodulators
Metallic implants =40cm from the planned alternating field, e.g. dental seals, cervical spine implants, implant remnants from previous craniotomies, orthopedic trauma osteosynthesis material, port systems with a metallic base
Electronic implants, e.g. cardiac pacemakers or defibrillators, cochlear implants, DBS
Allergy/hypersensitivity to aminosilanes, iron oxide, acetic acid
Planned or current therapy with Optune®TTF
Uncontrolled claustrophobia
Pain caused by arthrosis and degenerative spinal disorders, which may not be controlled
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: AE/SAE frequency (ask throughout the study)<br>Efficacy: OS-2 (survival after diagnosis of recurrence) ; evaluation at the end of the study.
- Secondary Outcome Measures
Name Time Method Quality of life after treatment with NanoTherm® Therapy System