Using NanoTherm therapy for recurrent glioblastoma multiforme

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of NanoTherm therapy in patients with recurrent glioblastoma multiforme (GBM). Participants will undergo initial assessments to determine eligibility and will receive NanoTherm therapy alongside standard treatments like glioma resection, radiotherapy, and chemotherapy as per the Stupp protocol. The study aims to measure overall survival, progression-free survival, and the tolerance of the therapy in terms of side effects and quality of life. The trial is designed to provide insights into a novel treatment approach for a challenging condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital
  Poznan, Poland Recruiting

Study contacts

• Principal investigator: Slawomir Michalak, Prof. — Poznan University of Medical Sciences
• Study coordinator: Slawomir Michalak, Prof.
• Email: swami@ump.edu.pl
• Phone: +48 61 8691 535

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.