protocolSection identificationModule nctId: NCT06271421, orgStudyIdInfo id: 01/24, briefTitle: NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme, acronym: ANCHIALE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Poznan University of Medical Sciences, class: OTHER, collaborators name: MagForce USA, descriptionModule briefSummary: 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 performed for routine postoperative evaluation;* after the first activation (10th day), the catheter will be removed;* subsequently, for 6 times, the patient will be subjected to the variable magnetic field of the NanoActivator® to induce hyperthermia - activations will be conducted on the 10th, 14th, 17th, 21st, 24th, and 28th day;* for up to 2 years post-procedure, a CT scan with an evaluation of treatment efficacy will be performed;* during follow-up visits for up to 2 years after the surgical procedure, a neurological examination, assessment of adverse symptoms, number of hospitalizations, number of medical visits, clinimetric assessment regarding quality of life, neurological deficit and degree of disability will be conducted.Researchers will compare NanoTherm group with patients undergoing Stupp protocol treatment for the abovementioned effects., conditionsModule conditions: Glioblastoma Multiforme, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective longitudinal study will be performed recurrent glioblastoma multiforme patients who:1. are included for NanoTherm therapy (group A),2. are included for standard Stupp protocol (surgery/chemo-radiotherapy) (group B), primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: ANCHIALE is open-label study, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: NanoTherm therapy, interventions name: Glioma Resection, interventions name: radiotherapy according to Stupp protocol, interventions name: chemotherapy according to Stupp protocol, outcomesModule primaryOutcomes measure: Survival following the surgery [units months 1-24], primaryOutcomes measure: Progression free survival [units months 1-24], secondaryOutcomes measure: Response Assessment in Neuro-oncology [1 - complete response; 4 -progressive disease], secondaryOutcomes measure: EuroQuality of Life 5-dimensions-5 levels scale (EQ-5D-5L) [arbitraty units 0- worst ; 100 - best], secondaryOutcomes measure: Neurologic Assessment in Neuro-Oncology (NanoScale 2) [0-best; 23-worst], secondaryOutcomes measure: modified Rankin scale [0-best; 6-worst], secondaryOutcomes measure: Barthel index [range 0-100; 0-best, 100-worst], eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital, status: RECRUITING, city: Poznań, zip: 60-355, country: Poland, contacts name: Slawomir Michalak, Prof., role: CONTACT, phone: +4861 8691 535, email: swami@ump.edu.pl, contacts name: Jakub Moskal, MD, PhD, role: CONTACT, phone: +4861 8691 422, email: jakub.moskal@usk.poznan.pl, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False