| NCT ID | NCT06136611 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Christie NHS Foundation Trust |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-12-19 |
| Primary Completion | 2026-09-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2024-12-19 with a primary completion date of 2026-09-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 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 Criteria: * 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06136611 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06136611 currently recruiting?
Yes, NCT06136611 is actively recruiting participants. Contact the research team at gerben.borst@nhs.net for enrollment information.
Where is the NCT06136611 trial being conducted?
This trial is being conducted at Manchester, United Kingdom.
Who is sponsoring the NCT06136611 clinical trial?
NCT06136611 is sponsored by The Christie NHS Foundation Trust. The trial plans to enroll 42 participants.
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