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| ID | Type | Description | Link |
|---|---|---|---|
| TSC/24/35 | Other Grant/Funding Number | Chief Scientist Office (CSO) of the Scottish Government |
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| Name | Class |
|---|---|
| NHS Grampian | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glioblastoma | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline Field-Cycling Imaging research scan | Other | FCI scan at baseline |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At six months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with long term tumour recurrence | Tumour recurrence identified in routine clinical MRI scans, for up to 5 years. | Up to five years after baseline. |
Inclusion Criteria:
Exclusion Criteria:
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Participants treated at Aberdeen Royal Infirmary with histologically confirmed newly diagnosed glioblastoma who have completed radical chemoradiation with 60 Gy in 30 fractions over 6 weeks radiotherapy to the tumour and concurrent temozolomide chemotherapy, and who are due to start adjuvant temozolomide 4 weeks after completion of chemoradiation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Kiltie, Prof | Contact | +44 1224438651 | anne.kiltie@abdn.ac.uk | |
| Rafael Moleron, Dr | Contact | rafael.moleron@nhs.scot |
| Name | Affiliation | Role |
|---|---|---|
| Anne Kiltie, Prof | University of Aberdeen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Aberdeen | Aberdeen | United Kingdom |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| Baseline 3T MRI research scan |
| Other |
MRI scan at baseline |
|
| Second Field-Cycling Imaging research scan | Other | FCI scan after three cycles of chemotherapy |
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| Second 3T MRI research scan | Other | MRI scan after three cycles of chemotherapy |
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| Final Field-Cycling Imaging research scan | Other | FCI scan at the end of chemotherapy |
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| Final 3T MRI research scan | Other | MRI scan at the end of chemotherapy |
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| At six months after baseline |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |