Condition: Glioblastoma Multiforme · Sponsor: Poznan University of Medical Sciences
Glioblastoma multiforme (GBM), the most common and malignant primary brain tumor in adults is classified as a World Health Organisation (WHO) grade 4. Surgical removal of the tumor is the primary method of treatment. Unfortunately, because GBM is a disease of the entire brain, total resection is not possible. Therefore, the use of radiotherapy and/or chemotherapy is considered as Stupp protocol. Patients with recurrent GBM will be included in the ANCHIALE study. The goal of the trial is to evaluate the efficacy and tolerance of using the NanoTherm therapy system in recurrent GBM. The main questions it aims to answer are: 1. how NanoTherm therapy influences overall survival, and progression free survival; 2. what is the tolerance of NanoTherm therapy in terms of side effects (allergies, intracranial bleeding, infections, brain edema, increased intracranial pressure) and quality of life. Participants will undergo: * initial visit, considering the inclusion/exclusion criteria, neurological examination, and surveys regarding daily functioning and quality of life; * standard neurosurgical operation aimed, if possible, complete removal of the recurrent GBM and administration of NanoTherm ASI - a sterile suspension of iron oxide nanoparticles. A catheter will be implanted allowing for measurement of temperature during the first activation in the magnetic field; * between the 6th and 10th day after tumor resection, a standard computerized tomography (CT) scan of the head will be…
This description comes directly from the study's public registry record.
Slawomir Michalak, Prof. · +48 61 8691 535 · swami@ump.edu.pl
Jakub Moskal, MD, PhD · +48 61 8691 422 · jakub.moskal@usk.poznan.pl
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| University Hospital | Poznan, Poland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06271421