ANCHIALEApplication of Nanoparticles for Cyclic Hyperthermia In Adjuvant Therapy of gLioblastoma Multiforme (ANCHIALE)
NanoTherm therapy
+ Glioma Resection
+ radiotherapy according to Stupp protocol
Hyperthermia+13
+ Astrocytoma
+ Body Temperature Changes
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy 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