Performance and Safety of thermotherapy with nanoparticles (NanoTherm® Therapy System) as an adjuvant therapy to the Standard of Care treatment of patients with recurrent glioblastoma

Performance and Safety of thermotherapy with nanoparticles (NanoTherm® Therapy System) as an adjuvant therapy to the Standard of Care treatment of patients with recurrent glioblastoma - The NanoTherm Registry

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023339

Enrollment

103

Registered

2020-10-19

Start date

2020-10-14

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C71.9

Interventions

Group 1: Treatment with "NanoTherm® Therapy System" (NanoTherm®, NanoActivator® and NanoPlan®), which is already certified throughout the EU for the targeted treatment of solid tumors through heat usi

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Male and female patients with recurrent glioblastoma (first or repeated recurrence) Age 18-75 Years Informed Consent in writing Karnofsky Index = 60 Life expectancy > 6 months Failed standard therapy (Stupp regiment, TTF) Stable corticoid requirements = 2mg dexamethasone / d Known Molecular differentiation (MGMT promoter methylation, IDH mutation status, 1p/19q deletion status) Cardiopulmonary compliance (heat and lying flat in the field generator for approx. 60 minutes must be tolerated Psychological resilience

Exclusion criteria

Exclusion criteria: Patients older than 75years Pregnant or breast-feeding women > 3 multiple glioblastoma lesions Speech or motor brain functions in/at resection area Subependymal contrast enhancement in adjacent ventricles Simultaneous therapy with immunomodulators Metallic implants =40cm from the planned alternating field, e.g. dental seals, cervical spine implants, implant remnants from previous craniotomies, orthopedic trauma osteosynthesis material, port systems with a metallic base Electronic implants, e.g. cardiac pacemakers or defibrillators, cochlear implants, DBS Allergy/hypersensitivity to aminosilanes, iron oxide, acetic acid Planned or current therapy with Optune®TTF Uncontrolled claustrophobia Pain caused by arthrosis and degenerative spinal disorders, which may not be controlled

Design outcomes

Primary

Measure	Time frame
Safety: AE/SAE frequency (ask throughout the study) Efficacy: OS-2 (survival after diagnosis of recurrence) ; evaluation at the end of the study.	—

Secondary

Measure	Time frame
Quality of life after treatment with NanoTherm® Therapy System	—

Countries

Germany, Italy, Poland, Spain

Contacts

Public ContactWalter Stummer

Universitätsklinikum - Münster

Walter.Stummer@ukmuenster.de+49 (0)251 83-47472

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026