Recruiting

ANCHIALEApplication of Nanoparticles for Cyclic Hyperthermia In Adjuvant Therapy of gLioblastoma Multiforme (ANCHIALE)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

NanoTherm therapy

+ Glioma Resection

+ radiotherapy according to Stupp protocol

DeviceProcedureRadiationDrug
Who is being recruted

Hyperthermia+13

+ Astrocytoma

+ Body Temperature Changes

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorPoznan University of Medical Sciences
Study ContactSlawomir Michalak, Prof.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on improving treatment outcomes for patients with recurrent glioblastoma multiforme, a highly aggressive brain tumor. Current treatments, including surgery, radiotherapy, and chemotherapy, have limited success in extending the survival of patients. Researchers are exploring the use of a new therapy called NanoTherm, which involves the use of nanoparticles to generate heat and potentially enhance the effectiveness of existing treatments. By targeting the tumor area with heat, this method aims to destroy cancer cells more effectively and improve patients' survival rates and quality of life. Participants in the study will undergo surgery to remove as much of the tumor as possible. After that, a special solution containing nanoparticles will be applied to the remaining tumor site. These nanoparticles are then activated by a magnetic field to produce heat, a process done cyclically over a series of days to damage the cancer cells. Throughout the study, participants will have regular check-ups, including CT scans and assessments of their neurological health, to evaluate the treatment's impact on their condition. The study will last for two years, and the results from the NanoTherm treatment will be compared to the outcomes of standard neurosurgical treatments to determine its effectiveness and safety.

Official TitleApplication of Nanoparticles for Cyclic Hyperthermia In Adjuvant Therapy of gLioblastoma Multiforme (ANCHIALE)
Principal SponsorPoznan University of Medical Sciences
Study ContactSlawomir Michalak, Prof.More contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperthermiaAstrocytomaBody Temperature ChangesGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesNeuroectodermal TumorsNeoplasms, NeuroepithelialHeat Stress Disorders

Criteria

7 inclusion criteria required to participate
Recurrence of glioblastoma multiforme.

Age > 18 years.

Informed written consent to participate in the study.

Karnofsky performance score ≥ 60.

Show More Criteria

11 exclusion criteria prevent from participating
Pregnant or breastfeeding women.

More than 3 foci of glioblastoma multiforme.

Tumor invasion of eloquent or motor areas.

Subependymal contrast enhancement in the adjacent brain ventricles.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Recurrent glioblastoma multiforme patients treated with NanoTherm therapy.

Group II

Placebo
Glioblastoma multiforme patients treated according to Stupp protocol including surgery, chemotherapy and radiotherapy.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University Hospital

Poznan, PolandOpen University Hospital in Google Maps
Recruiting
One Study Center
ANCHIALE | Application of Nanoparticles for Cyclic Hyperthermia In Adjuvant Therapy of gLioblastoma Multiforme (ANCHIALE) | PatLynk