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Enrolling by invitation NCT07634575

Triggered Imaging in Glioblastoma Based on Clinical Outcome Evaluation Compared to Routine: a Feasibility Study

No phase Interventional Glioblastoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: triggered imaging.
Who it may be relevant to
Registry conditions: Glioblastoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This is a feasibility randomized controlled trial comparing triggered imaging based on patient symptom self-reporting and performance-based measures with the existing imaging schedule.

Detailed description

Patients in intervention arm will be invited to complete weekly online symptom questionnaires. Responses will be evaluated and given a score, with higher scores reflecting 'red flag' symptoms or symptoms of a severity which meet pre-defined thresholds.

Interventions

  • Diagnostic test triggered imaging
    triggered imaging for symptoms as opposed to routine interval imaging

Primary outcome measures

  • The primary outcomes are: - Number of patients willing to self-report symptoms on an online app - Number of patients willing to undertake cognitive testing - Number of complete symptom questionnaires and assessments - Number of fast track MRI [Time frame: From enrollment up to 12 months]
  • The primary outcomes are: - Number of patients willing to self-report symptoms on an online app - Number of complete symptom questionnaires and assessments - Number of fast track MRI [Time frame: From enrollment up to 12 months]

Eligibility criteria

Inclusion criteria

i. Newly diagnosed glioblastoma (WHO grade IV) ii. Planned to undergo the Stupp treatment regimen iii. Aged 18-70 iv. To be treated at KCH and GSTT v. No MRI contraindications vi. Patients with internet access and an e-mail account

Exclusion criteria

i. Uncertainty of diagnosis ii. Deviation from the standard Stupp regimen iii. Patients participating in another interventional study iv. Unable to read and comprehend English language text v. Lack capacity at point of consent vi. WHO Performance status > 3 (Karnofsky score < 30)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United Kingdom · 1 center
  • KCH — London

Identifiers

NCT: NCT07634575 · KCH22-151

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗