At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- TTFields (device)
- How long the study runs
- Study runs about 24 months (dates as stated)
- About the drug or intervention
- TTFields — device: 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 35 Years and over
- Who
- All
- Number of participants
- 42
- Started
- 2024-12-19
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for glioblastoma
- • NA - 42 participants
- • 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)
Who can take part?
- • Ages 35 Years and over
- • Diagnosed with glioblastoma
Where?
- • Manchester - The Christie NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Glioblastoma is the most common primary malignant brain tumour in adults. Its outcomes are poor due to local disease progression in most patients. Current treatment includes surgery followed by chemotherapy and radiotherapy 4-6 weeks after surgery. In this time interval, some tumour cells do not receive any treatment. Furthermore, studies show that around half of all glioblastoma patients experience rapid early progression (REP) i.e. growth of the tumour in the time interval between surgery and postoperative chemotherapy/radiotherapy. REP is associated with a shorter survival and there are currently no effective treatments or preventative measures to address it. Tumour Treating Fields (TTFields), also known as Optune, is a locally applied treatment modality that has contributed to a better survival outcome for glioblastoma patients when used after surgery and chemo-radiotherapy. The investigators hypothesize that earlier treatment using the Optune device before the surgery and between the surgery and postoperative radiotherapy can prevent REP and improve patient outcome. The PORTRAIT (PreOpeRaTive pRerAdIotherapy Ttfields) phase 1 trial will test the safety and feasibility of Optune treatment before surgery and before post-operative radiotherapy in a maximum of 14 patients. Participants will be required to undergo additional MRI sequencing scans and provide blood, tear fluid and tissue samples over a maximum of 6 months. A non-experimental arm (Non-EA) of 28 patients will allow comparisons of data collected from PORTRAIT experimental arm patients with comparable Standard of Care (SoC) treated patients from the same time frame. This will maximise PORTRAIT's translational and clinically relevant components. Participants will be invited to the research study if they are over the age of 35 and have a new radiological diagnosis of glioblastoma. All recruitment and treatment will be conducted at the Christie NHS Foundation Trust and Northern Care Alliance NHS Foundation Trust. The study is funded by a research grant from Novocure.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 35 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ duration
What 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...
- ✓Patient is male or female.
- ✓Patient has a new radiological diagnosis of glioblastoma.
- ✓Patient has a performance status judged by WHO, activity scale (ECOG) score = 0-1.
- ✓PI has confirmed at the first clinic visit that study entry is clinically appropriate and safe (e.g. lack of severe...
Who cannot take part
- ✗Patients with uncontrolled seizures.
- ✗Patients are due to undergo a planned biopsy procedure only.
- ✗Patients have contraindications to contrast-enhanced MRI scanning (e.g. claustrophobia, gadolinium allergy).
See the full criteria
Where Is This Study? (1 UK site)
The Christie NHS Foundation Trust
Manchester M204BX, United Kingdom
How to Get in Touch
Gerben R Borst, MD PhD
Sponsor contactCONTACT
Melanie Oddy
Sponsor contactCONTACT
