Preoperative Preradiotherapy TTFields

Recruiting now · Not applicable

Conditions studied: Glioblastoma

In brief

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.

Key facts

Study ID

NCT06136611

Run by

The Christie NHS Foundation Trust

People needed

42

Starts

2024-12-19

Expected to finish

2026-12-30

Last updated by the study team

2026-05-08

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• The Christie NHS Foundation Trust — Manchester, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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