NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme
Sponsored by Poznan University of Medical Sciences
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Started 2 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. Recurrence of glioblastoma multiforme.
2. Age > 18 years.
3. Informed written consent to participate in the study.
4. Karnofsky performance score ≥ 60.
5. Expected survival time > 6 months.
6. Failure of standard treatment according to the Stupp protocol.
7. Cardio-respiratory fitness - allowing to stay for 60 minutes in a lying position in the field activator.
Exclusion Criteria
1. Pregnant or breastfeeding women.
2. More than 3 foci of glioblastoma multiforme.
3. Tumor invasion of eloquent or motor areas.
4. Subependymal contrast enhancement in the adjacent brain ventricles.
5. Concurrent immunotherapy for glioblastoma.
6. Metal implants within ≤ 40 cm of the planned exposure field: metal dental fillings/restorations, cervical spine implants, metal elements left after previous craniotomies, metal elements used in osteosynthesis after orthopedically treated injuries, vascular ports with metal components.
7. Electronic implants: pacemakers, cardioverter defibrillators, cochlear implants, deep brain stimulation (DBS) electrodes.
8. Allergy/hypersensitivity to aminosilanes, iron oxide, acetic acid.
9. Planned or current treatment with electromagnetic field in the Optune®TTF system.
10. Claustrophobia not amenable to control.
11. Painful conditions, musculoskeletal system diseases that prevent staying in a lying position.
