Blood-Brain Barrier Disruption with Exablate for Recurrent Glioblastoma Treatment
Exablate BBBD
+ Carboplatin
Astrocytome+7
+ Glioblastome
+ Gliome
Étude thérapeutique
Résumé
Date de début de l'étude : 13 octobre 2020
Date à laquelle le premier participant a commencé l'étude.This study focuses on treating recurrent Glioblastoma (rGBM), a type of brain tumor, using a combination of blood-brain-barrier disruption (BBBD) and carboplatin chemotherapy. The blood-brain barrier is a protective shield that sometimes prevents medicines from reaching the brain. This study uses a device called Exablate Neuro Model 4000 Type 2 to temporarily open this barrier, allowing the chemotherapy drug, carboplatin, to reach the tumor more effectively. Adults with glioblastoma who are planned for carboplatin chemotherapy may be considered for this study. The goal is to establish the safety and feasibility of this combined approach, which could potentially improve treatment outcomes for this condition. During the study, participants will undergo up to 6 cycles of Exablate BBBD procedures in conjunction with carboplatin chemotherapy. The effectiveness of the BBBD procedure will be measured by the intensity of contrast in the treated areas on MRI scans. Any adverse events or side effects will be documented and reported according to standard medical criteria. This helps ensure the safety of the participants and provides valuable information about the potential risks and benefits of this treatment approach.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.13 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 80 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Must be between 18-80 years old * Histologically confirmed glioblastoma * Planned for Carboplatin monotherapy * Be willing and able to provided written informed consent/assent * Tumor progression after first line therapy * Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy * Women of childbearing potential is confirmed not pregnant. Male and Female subjects utilize highly effective contraception * Able to communicate verbally Exclusion Criteria: * Acute intracranial hemorrhage * Ferrous metallic implanted objects in the skull or brain * Prior toxicity with carboplatin chemotherapy * Women who are pregnant or breastfeeding * Cerebellar spinal cord or brain stem tumor * Known active Hepatitis B or Hepatitis C or HIV * Significant depression not adequately controlled * Cardiac disease or unstable hemodynamics * Severe hypertension * History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage * Active drug or alcohol use disorder * Known sensitivity to gadolinium-based contrast agents * Known sensitivity or contraindications to ultrasound contrast agent or perflutren * Unable to undergo MRI or contraindications to MRI such as non-MRI compatible implanted devices * Difficulty lying supine and still or severe claustrophobia which cannot be managed with medication * Severely impaired renal function * Right to left or bi-directional cardiac shunt * Cranial or systemic infection requiring antibiotics * Known additional malignancy that is progression or require active treatment
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 3 sites
Sunnybrook Health Sciences Centre
Toronto, CanadaOuvrir Sunnybrook Health Sciences Centre dans Google MapsFondazione IRCCS Neurologico Carlo Besta
Milan, ItalyYonsei University Medical Center
Seoul, South Korea