Preoperative Preradiotherapy TTFields
Preoperative Preradiotherapy TTFields (PORTRAIT)
The Christie NHS Foundation Trust
42 participants
Dec 19, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- 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 appropriate and safe (e.g. lack of severe and debilitating symptoms of raised intracranial pressure).
- There is intention to treat the patient with surgical resection and postoperative adjuvant therapy as per current standard of care (40Gy/15 fr or 60Gy/30fr).
- Patient has adequate haematological and biochemical parameters for surgery and contrast agent administration (full blood count and coagulation profile deemed acceptable by clinical team, eGFR >30ml/min).
- Patient has mental capacity to consent for treatment.
- Patient is able and willing to give informed consent
- Criteria specific to the experimental arm:
- Patient is able and willing to comply with study protocol requirements to continuously shave their head
- Patient is able and willing to comply with study protocol requirements to wear Optune equipment for the required duration.
Exclusion Criteria4
- Patients with uncontrolled seizures.
- Patients are due to undergo a planned biopsy procedure only.
- Patients have a suspicion of other tumour on CT body scan or known malignancy except non-melanoma skin cancer, completely resected or prostate cancer (with Prostate Specific Antigen of less than or equal to 0.1 ng/ml) within the past three years.
- Patients have contraindications to contrast-enhanced MRI scanning (e.g. claustrophobia, gadolinium allergy).
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Interventions
TTFields will be delivered through 4 transducer arrays with 9 insulated electrodes each placed on the shaved scalp and connected to a portable device set to generate 200-kHz electric fields within the brain.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06136611