- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07634575
Triggered Imaging in Glioblastoma Based on Clinical Outcome Evaluation Compared to Routine: a Feasibility Study (TIGER F)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- KCH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic Test: triggered imaging Description: triggered imaging for symptoms as opposed to routine
1
|
triggered imaging for symptoms as opposed to routine interval imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
From enrollment up to 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioblastoma
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Cardiac Imaging Techniques
- Cardiac-Gated Imaging Techniques
Other Study ID Numbers
- KCH22-151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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