Blood-Brain Barrier Disruption with Exablate for Recurrent Glioblastoma Treatment
Exablate BBBD
+ Carboplatin
Astrocitoma+5
+ Glioblastoma
+ Glioma
Estudio de Tratamiento
Resumen
Fecha de inicio: 13 de octubre de 2020
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 13 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 80 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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 Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 3 ubicaciones
Sunnybrook Health Sciences Centre
Toronto, CanadaAbrir Sunnybrook Health Sciences Centre en Google MapsFondazione IRCCS Neurologico Carlo Besta
Milan, ItalyYonsei University Medical Center
Seoul, South Korea