An interventional study of TTFields in Glioblastoma, sponsored by The Christie NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by The Christie NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 42 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →The Christie NHS Foundation Trust is the lead sponsor of 99 studies on the registry; 25 are open to participants now.
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Criteria specific to the experimental arm:
Exclusion Criteria:
Patients will apply TTFields (a treatment device referred to as Optune) before surgery and continue using this once the stitches are removed (approximately one to two weeks after surgery). Patients will wear the Optune application for 2 to 3 weeks before their standard-of-care (SoC) surgery and 3 to 4 weeks after the surgery (while awaiting their postoperative radiotherapy). Treatment with 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.
Device: TTFields
Patients will follow the routine care pathway for glioblastoma and timings of the following will be determined by the clinical team.
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.
To determine the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Pre-Operative and Pre-Radiotherapy TTFields additional to the standard treatment of care (SoC) including adjuvant TTFields.
This endpoint will be tested by skin toxicity / wound complications. Toxicity is defined using CTCAE v5.0 and study related complications are defined as; * Skin toxicity grade 3 or higher * Wound closure or wound healing problems grade 2 or higher that are possibly related to TTFields treatment
Time frame: 18 months
To determine the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Pre-Operative and Pre-Radiotherapy TTFields additional to the standard treatment of care (SoC) including adjuvant TTFields.
This endpoint will be tested by alterations to the original date of surgery and the start of the postoperative radiotherapy; Study related complications will be defined as; * Change of surgery date due to symptoms related to the tumour that are possibly related to the TTFields treatment * Delay of start of the postoperative radiotherapy (RT) possibly related to the TTFields treatment (later than 6 weeks postoperative)
Time frame: 18 months
Concordance between MRI based diagnosis of glioblastoma and definitive histological diagnosis
Evaluate the use of MRI to select glioblastoma patients for PORTRAIT without pathological confirmation.
Time frame: 18 months
REP: tumour volume difference between the post-operative MRI and pre-radiotherapy MRI.
Evaluate the effect of TTFields on REP - tumour growth between surgery and postoperative chemoradiotherapy, in patients with a new diagnosis of glioblastoma. A lower value represents a better outcome.
Time frame: 18 months
Registration of postoperative surgical complications
Postoperative surgical complications (e.g. haemorrhage, wound infection, delayed wound healing, seizures). Lower registrations represents a better outcome.
Time frame: 18 months
Registration of radiotherapy related complications
Radiotherapy related complications (e.g. radiation necrosis). Lower registrations represents a better outcome.
Time frame: 18 months
Steroid dose after TTFields
Steroid dose recorded after TTFields until the start of the postoperative RT. Lower (or absence of) dose represents a better outcome.
Time frame: 18 months
Progression free survival
Time period from the date of surgery to the date of the MRI scan demonstrating first progression as determined by the neuro-oncology MDT. A longer time period represents a better outcome.
Time frame: 18 months
Overall survival
Time period from the date of surgery to the date of death. A longer time period represents a better outcome.
Time frame: 18 months
Collection of liquid biopsies
Collection of blood and tear fluid samples at matched imaging timepoints.
Time frame: 18 months
Skin reactions
Skin reactions defined by CTCAE V5.0 - a rating scale of 1 to 5. 1 indicates minimal toxicity (skin irritation etc), 5 indicates death - or life threatening complications.
Time frame: 18 month
Plan to share: Yes — Anonymised Individual Participant Data (IPD) relating to specified clinical outcomes may be shared upon request. A Sponsor approved Data Management Plan will detail the full sharing criteria and agreements.
Supporting information: Study protocol, Sap
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