Actively Recruiting
NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme
Led by Poznan University of Medical Sciences · Updated on 2024-02-26
100
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
P
Poznan University of Medical Sciences
Lead Sponsor
M
MagForce USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recurrence of glioblastoma multiforme.
- Age over 18 years.
- Informed written consent to participate in the study.
- Karnofsky performance score of 60 or higher.
- Expected survival time greater than 6 months.
- Failure of standard treatment according to the Stupp protocol.
- Cardio-respiratory fitness allowing to stay for 60 minutes lying in the magnetic field activator.
You will not qualify if you...
- Pregnant or breastfeeding women.
- More than 3 foci of glioblastoma multiforme.
- Tumor invasion of eloquent or motor brain areas.
- Subependymal contrast enhancement in adjacent brain ventricles.
- Receiving concurrent immunotherapy for glioblastoma.
- Metal implants within 40 cm of the planned exposure field, including dental fillings, spine or craniotomy implants, osteosynthesis elements, or vascular ports.
- Electronic implants such as pacemakers, defibrillators, cochlear implants, or deep brain stimulation electrodes.
- Allergy or hypersensitivity to aminosilanes, iron oxide, or acetic acid.
- Planned or current treatment with Optune TTF electromagnetic field therapy.
- Claustrophobia that cannot be controlled.
- Painful musculoskeletal conditions preventing lying down for treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital
Poznan, Poland, 60-355
Actively Recruiting
Research Team
S
Slawomir Michalak, Prof.
CONTACT
J
Jakub Moskal, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here