TIGER F
Research type
Research Study
Full title
Triggered post-treatment Imaging in Glioblastoma based on clinical outcome Evaluation compared to Routine: a feasibility study
IRAS ID
299004
Contact name
Aysha Luis
Contact email
Sponsor organisation
King’s College Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 10 months, 7 days
Research summary
Glioblastoma is the most common brain tumour in adults associated with a high symptom burden and poor prognosis. Currently, patients with glioblastoma undergo imaging at set time points, known as surveillance imaging, to look for tumour growth and check whether tumours are responding to treatment. Yet, it is not known whether scanning at these specific times changes patient outcomes such as survival. In addition, frequent imaging and uncertainty regarding tumour recurrence can cause unnecessary anxiety and increase in symptom severity, which can negatively affect a patients’ quality of life (QoL).
In this feasibility study, we propose an alternative approach, which is looking into triggered imaging based on patient reported outcome (PRO) and performance-based outcome (PerfO) measures. PROs are directly reported by the patient and reflects their own perception of symptoms and function associated with the disease or treatment. There are indications PROs can contribute to improved survival and maintaining an optimal quality of life in other oncology populations. PerfO measures in contrast, are usually administered by a health care professional and performed by the patient,
Eligible patients will be recruited from neuro-oncology clinics and randomized into an intervention and control group. Patients in the intervention arm will be invited to complete weekly online symptom questionnaires as well as undertake monthly cognition tests. Self-reporting of severe or worsening symptoms which meet pre-defined threshold criteria, as well as decline in cognitive function, will trigger notification alerts to the research and clinical team, who will be able to expedite a fast track MRI.
This comprehensive approach of active symptom monitoring and cognitive testing can provide a better picture of overall disease status and functional ability, facilitating the development of patient reported and machine learning biomarkers with potential to inform future imaging guidelines and practices.
REC name
London - Harrow Research Ethics Committee
REC reference
21/LO/0819
Date of REC Opinion
9 Sep 2022
REC opinion
Further Information Favourable Opinion