NCT06136611Recruiting
Preoperative Preradiotherapy TTFields
Preoperative Preradiotherapy TTFields (PORTRAIT)
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 9 Jan 2023
- Start date
- 19 Dec 2024
- Primary completion date
- 3 Sept 2026
- Lead sponsor
- The Christie NHS Foundation Trust
- Diseases
- Glioblastoma
- NCT number
- NCT06136611
What you commit to
- Study type: Interventional
- Planned participants: 42
- From 19 Dec 2024 to the primary completion date, 3 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with uncontrolled seizures.
- 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).
Other
- Patients are due to undergo a planned biopsy procedure only.
Who the study is looking for
- 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.
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.