Preoperative Preradiotherapy TTFields
PreOperative PreRAdIotherapy Tumour Treating Fields (PORTRAIT) is a Phase I study that will test the safety and feasibility of Optune administered preoperatively and preradiotherapy in patients with a new radiological diagnosis of glioblastoma (GBM). Participants will be required to undergo additional MRI sequencing sc
| Condition(s) | Glioblastoma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | PreOperative PreRAdIotherapy Tumour Treating Fields (PORTRAIT) is a Phase I study that will test the safety and feasibility of Optune administered preoperatively and preradiotherapy in patients with a new radiological diagnosis of glioblastoma (GBM). Participants will be required to undergo additional MRI sequencing scans and provide blood, tear fluid and tissue samples over a maximum of 6 months. After the study patients will follow their standard treatment pathway. |
| Who can participate | Inclusion Criteria: * Patient is aged \>35 years (age range of more likely to suffer from an IDHwt World Health Organisation (WHO) grade 4 astrocytoma)\* * Patient is male or female. * Patient has a new radiological diagnosis of glioblastoma. * Patient has a performance status judged by WHO, Eastern Cooperative Oncology Group (ECOG) score = 0-1. * Patient has been reviewed by Neuro-oncology multidisciplinary team (MDT - neurosurgeon, clinical oncologist, radiologist and pathologist); MDT consensus that offering study entry is clinically appropriate and safe i.e. patient unlikely to come to harm (e.g. hydrocephalus) from delayed surgery and pre-operative Optune based on available clinical information and imaging. * PI has confirmed at the first clinic visit that study entry is clinically ap |
| Ages | 35 Years |
| Sex | All |
| Lead sponsor | The Christie NHS Foundation Trust |
| Locations | Manchester, United Kingdom |
| Start date | 2024-12-19 |
| NCT ID | NCT06136611 |
| Official listing | https://clinicaltrials.gov/study/NCT06136611 |