Pre-surgery and pre-radiotherapy Tumour Treating Fields (Optune) for glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PORTRAIT is a Phase I safety and feasibility trial of applying Tumour Treating Fields (Optune) before surgery and again prior to postoperative radiotherapy in adults with newly diagnosed glioblastoma. Up to 14 patients will receive preoperative and preradiotherapy Optune, alongside a non-experimental cohort of about 28 patients for comparison. Participants will undergo additional MRI sequences and give blood, tear fluid, and tissue samples with follow-up over a maximum of six months. The main aims are to document safety, feasibility of device use in these time windows, and to collect imaging and biomarker data related to early tumour progression.

Why it matters

Who can join: the full rules

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).

Where it's running

• The Christie NHS Foundation Trust
  Manchester, United Kingdom Recruiting

Study contacts

• Study coordinator: Gerben R Borst, MD PhD
• Email: gerben.borst@nhs.net
• Phone: 0161 446 3000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.