Gliobastoma Cancer
Conditions
Interventions
Participants can undergo SDT with MRgFUS treatment a week before they are scheduled for surgery.
Three hours prior to the scheduled SDT procedure, participants will receive a dose of 20 mg/kg adminis
Sponsors
Imperial College Healthcare NHS Trust
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Men and women between 18 and 70 years 2. Suspected primary lobar glioblastoma clearly measurable on the basis of Response Assessment in Neuro-Oncology (RANO) criteria 3. Brain glioblastomas located in a surgically accessible brain region for resection 4. The targeted tumour resection volume measures between 1 and 5 cm in diameter 5. Karnofsky rating 70-100 6. ASA score 1-314 7. Able to attend all study visits 8. Able and willing to give informed consent
Exclusion criteria
Exclusion criteria: 1. Brain glioblastoma presenting with the following characteristics: 1.1. Brain oedema and/or mass effect that causes midline shift of more than 10 mm 1.2. Evidence of recent intracranial haemorrhage within the targeted tumour volume 1.3. Calcifications in the focused ultrasound sonication path (system tools may not tailor the treatment around these calcifications) 2. The sonication pathway to the tumour involves either: 2.1. More than 30% of the skull area traversed by scars, scalp disorders (e.g. eczema), or atrophy of the scalp 2.2. Clips, shunts, or other metallic implanted objects in the skull or the brain 3. Cardiac disease or unstable hemodynamic status including: 3.1. Documented myocardial infarction within six months of enrolment 3.2. Unstable angina on medication 3.3. Congestive heart failure 4. Severe hypertension 5. Anti-coagulant therapy or medications known to increase risk of haemorrhage within washout period prior to treatment. 6. History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor haemorrhage 7. Abnormal level of platelets (1.3 8. Cerebral or systemic vasculopathy 9. Known allergy sensitivity or contraindications to gadolinium 10. Contraindications to MRI such as non-MRI-compatible implanted devices 11. Subjects not fitting comfortably into the MRI scanner 12. Difficulty lying supine and still for up to 4 hours in the MRI unit or claustrophobia 13. Positive pregnancy test (for pre-menopausal women) 14. Severely impaired renal function with estimated glomerular filtration rate <30 ml/min/1.73m2 and/or on dialysis 15. Respiratory: chronic pulmonary disorders, e.g. severe emphysema, COPD, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area 16. Any illness or medical condition that in the investigator’s opinion precludes participation in this study 17. Patients unable to sign a consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Safety will be evaluated by patient examination and MRI images during the treatment, immediately post-treatment and on day 1 and week 1 post-treatment. Feasibility: The extent of the sonicated area will be calculated at the end of the procedure in order to evaluate the targeted area. Tumour regression will be determined by contrast enhancement on post-procedural serial contrast-enhanced MR images. Pathological examination and immunohistochemistry of the resected specimen will also be utilized to verify the amount of cell apoptosis and necrosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Tumour volume changes post-procedure according to MRI imaging immediately post-treatment and on day 1 and week 1 post-treatment | — |
Countries
United Kingdom
Outcome results
None listed