Clinical trial · Observational
FCI-Glioblastoma Study
Applying New MRI Technology to Improve Outcomes From Chemoradiotherapy Treatment for Adult Patients With Glioblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastom WHO Grade 4 | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Baseline 3T MRI research scan | Other | — | UNRESOLVED |
| Baseline Field-Cycling Imaging research scan | Other | — | UNRESOLVED |
| Final 3T MRI research scan | Other | — | UNRESOLVED |
| Final Field-Cycling Imaging research scan | Other | — | UNRESOLVED |
| Second 3T MRI research scan | Other | — | UNRESOLVED |
| Second Field-Cycling Imaging research scan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Glioblastoma
- description
- Participants with histologically confirmed newly diagnosed glioblastoma who have completed radical chemoradiation and are due to start adjuvant chemotherapy 4 weeks after completion of chemoradiation.
- interventionNames
- Other: Baseline Field-Cycling Imaging research scan
- Other: Baseline 3T MRI research scan
- Other: Second Field-Cycling Imaging research scan
- Other: Second 3T MRI research scan
- Other: Final Field-Cycling Imaging research scan
- Other: Final 3T MRI research scan
Primary outcomes (1)
- measure
- 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.
- timeFrame
- At six months after baseline
- description
- R1 maps will be generated from FCI data acquired at each field using a multi-field fitting approach. R1 values will be extracted from the co-registered 3T tissue maps and compared between tissue types and with 3T measures of tissue physiology such as perfusion, ADC, FA and T2\*. The dispersion profiles will be fitted using a power law model to extract the scaling factor (A) and the exponent (β), with adaptations if required.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available