Glioblastom WHO Grade 4
Conditions
Keywords
Glioblastoma, Field-Cycling Imaging, FCI, MRI
Brief summary
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
OTHERBaseline Field-Cycling Imaging research scan
FCI scan at baseline
OTHERBaseline 3T MRI research scan
MRI scan at baseline
OTHERSecond Field-Cycling Imaging research scan
FCI scan after three cycles of chemotherapy
OTHERSecond 3T MRI research scan
MRI scan after three cycles of chemotherapy
OTHERFinal Field-Cycling Imaging research scan
FCI scan at the end of chemotherapy
OTHERFinal 3T MRI research scan
MRI scan at the end of chemotherapy
Sponsors
University of Aberdeen
NHS Grampian
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | At six months after baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | At six months after baseline | For identification of potential biomarkers, FCI images will be registered to the MRI images to obtain the T1 NMRD profiles of the pseudo-progressions. Dispersions models will be applied similarly to previous in vitro studies and comparison tests will be used to determine the best biomarker candidates that discriminate tumour residues from total clearance. |
Countries
United Kingdom
Contacts
CONTACTAnne Kiltie, Prof
CONTACTRafael Moleron, Dr
STUDY_CHAIRAnne Kiltie, Prof
University of Aberdeen
Outcome results
None listed