FCI-Glioblastoma Study
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: Baseline Field-Cycling Imaging research scan, Baseline 3T MRI research scan, Second Field-Cycling Imaging research scan, Second 3T MRI research scan.
- Who it may be relevant to
- Registry conditions: Glioblastom WHO Grade 4. Basic parameters: 18 years — 70 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 →
Official title
Applying New MRI Technology to Improve Outcomes From Chemoradiotherapy Treatment for Adult Patients With Glioblastoma
Overview
The goal of this study is to test if a new type of MRI scanner, called Field-Cycling Imaging (FCI), can tell the difference between tumour growth (progression) and 'pseudo-progression' (which looks like tumour but is not cancerous tissue) in patients with glioblastoma. The main question it aims to answer is: • Can FCI differentiate glioblastoma progression from pseudo-progression? Participants will undergo a standard MRI scan and an FCI scan, three times during the study. One before starting adjuvant chemotherapy, another one after three cycles and one at the end of treatment.
Interventions
- Other Baseline Field-Cycling Imaging research scan
FCI scan at baseline - Other Baseline 3T MRI research scan
MRI scan at baseline - Other Second Field-Cycling Imaging research scan
FCI scan after three cycles of chemotherapy - Other Second 3T MRI research scan
MRI scan after three cycles of chemotherapy - Other Final Field-Cycling Imaging research scan
FCI scan at the end of chemotherapy - Other Final 3T MRI research scan
MRI scan at the end of chemotherapy
Primary outcome measures
- Comparisons of FCI with a) the MRI images at 6 months from start of chemotherapy (tumour/no tumour) and, b) clinical judgement of Consultant Clinical Oncologist and Consultant Neuroradiologist on presence of tumour (or not) at 6 months. [Time frame: At six months after baseline]
Secondary outcome measures (1)
- Identifying unique imaging biomarkers of tissue structure that yield additional diagnostic information over existing non-invasive imaging methods, which could be tested in future clinical trials. [Time frame: At six months after baseline]
Eligibility criteria
Inclusion criteria
- Patients scheduled to have standard adjuvant temozolomide treatment for glioblastoma, within four weeks following radical radiotherapy with concomitant temozolomide
- 18 to 70 years old
- Life expectancy at least 12 weeks
- Able to undergo MRI scans lasting up to 1 hour each
- On stable or reducing dose of steroids for at least 5 days
- Able to provide informed consent
- Able to understand written and spoken English
Exclusion criteria
- Previous treatment for glioblastoma other than surgery and chemoradiation.
- Previous radiotherapy to brain and/or prior chemotherapy for lower grade glioma.
- Planned additional treatment with Tumor-Treating Fields
- Previous cytotoxic wafers or implants at the time of neurosurgery
- Uncontrolled intercurrent illness
- Being pregnant or nursing
- Conventional MRI contraindications
- Known allergy to contrast agent
- Unable to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- University of Aberdeen — Aberdeen
Identifiers
NCT: NCT07443176 · 2-080-25 · TSC/24/35