GlioblastomaPORTRAITNCT06136611
Preoperative Preradiotherapy TTFields
A study testing TTFields in people with Glioblastoma, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- TTFields
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Dec 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Melanie Oddy contact
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation Trust
Manchester, M204BX
About this study
Official title: Preoperative Preradiotherapy TTFields (PORTRAIT)
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.
Read the detailed description
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.
- Conditions
- Glioblastoma
- Being tested
- TTFields
- Keywords
- Neoadjuvant, Preoperative, Tumour Treating Fields
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTFieldsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Optune | Experimental | 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. Receives: Device: TTFields |
| Non-Experimental Arm | No intervention | Patients will follow the routine care pathway for glioblastoma and timings of the following will be determined by the clinical team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 18 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 18 months
Registration of radiotherapy related complications
Radiotherapy related complications (e.g. radiation necrosis). Lower registrations represents a better outcome.
Measured: 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.
Measured: 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.
Measured: 18 months
Overall survival
Time period from the date of surgery to the date of death. A longer time period represents a better outcome.
Measured: 18 months
Collection of liquid biopsies
Collection of blood and tear fluid samples at matched imaging timepoints.
Measured: 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.
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Dec 2024
- Primary completion3 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- PORTRAIT is a cohort study including: 14 prospective patients for the experimental arm which assumes a TRUE toxicity rate of 20% (the study needs 13 patients and we allow 1 patient for replacement). This means that there is less than 10% chance that 4 or more patients will experience a toxicity defined as a complication. For the non-experimental arm, 28 prospective patients will be recruited.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Northern Care Alliance NHS Foundation Trust, NovoCure Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136611
- Sponsor's protocol ID
- CFTSp221
- Other IDs
- 319109
- Acronym
- PORTRAIT
- Status last verified
- May 2026
- First submitted
- 9 Jan 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Preradiotherapy TTFields (PORTRAIT)
- ClinicalTrials.gov ID
- NCT06136611
- Acronym / sponsor ID
- PORTRAIT / CFTSp221
- Conditions
- Glioblastoma
- Keywords
- Neoadjuvant, Preoperative, Tumour Treating Fields
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Manchester, Northern Care Alliance NHS Foundation Trust, NovoCure Ltd.
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 3 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PORTRAIT is a cohort study including: 14 prospective patients for the experimental arm which assumes a TRUE toxicity rate of 20% (the study needs 13 patients and we allow 1 patient for replacement). This means that there is less than 10% chance that 4 or more patients will experience a toxicity defined as a complication. For the non-experimental arm, 28 prospective patients will be recruited.
| Arm | Type | Receives |
|---|---|---|
| Optune | Experimental | Device: TTFieldsPatients 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. |
| Non-Experimental Arm | No intervention | –Patients will follow the routine care pathway for glioblastoma and timings of the following will be determined by the clinical team. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTFieldsTTFields 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 | Optune |
Primary outcome
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.
Time frame: 18 months
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
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.
Time frame: 18 months
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)
9 secondary outcomes
Concordance between MRI based diagnosis of glioblastoma and definitive histological diagnosis
Time frame: 18 months
REP: tumour volume difference between the post-operative MRI and pre-radiotherapy MRI.
Time frame: 18 months
Registration of postoperative surgical complications
Time frame: 18 months
Registration of radiotherapy related complications
Time frame: 18 months
Steroid dose after TTFields
Time frame: 18 months
Progression free survival
Time frame: 18 months
Overall survival
Time frame: 18 months
Collection of liquid biopsies
Time frame: 18 months
Skin reactions
Time frame: 18 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melanie Oddy contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TTFields in people with Glioblastoma, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerben R Borst, MD PhD (0161 446 3000, gerben.borst@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.