RecruitingNot ApplicableNCT06136611

Preoperative Preradiotherapy TTFields

Preoperative Preradiotherapy TTFields (PORTRAIT)


Sponsor

The Christie NHS Foundation Trust

Enrollment

42 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

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). 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.


Eligibility

Min Age: 35 Years

Inclusion Criteria13

  • 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 Criteria4

  • 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).

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Interventions

DEVICETTFields

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.


Locations(1)

The Christie NHS Foundation Trust

Manchester, United Kingdom

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NCT06136611


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