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Glioma is the most common primary malignant brain tumour in adults and has an extremely poor prognosis. Glioblastoma is the most common subtype and its most aggressive form, with an annual incidence of 3.19 cases per 100,000.
The aim of this study is to quantify the degree of fatty acid oxidation in 20 participants diagnosed with glioblastoma multiforme (GBM) that have undergone surgical resection throughout the course of their chemotherapy and radiotherapy treatment.
The investigators hypothesise that the parameters derived from longitudinal 18F-fluoropivalate (18F-FPIA) positron emission tomography (PET) will change predictably over the course of therapy in relation to response.
Twenty evaluable participants with histologically confirmed glioblastoma multiforme (GBM) following surgical resection that are due to undergo treatment with chemoradiotherapy (CRT) will be enrolled into the study. The patients invited to participate in the study will provide written informed consent, but will only undergo 18F-FPIA positron emission tomography-computerised tomography (PET-CT) imaging once they have satisfied the inclusion and exclusion criteria. Once these criteria have been satisfied, eligible participants will proceed with a 18F-FPIA PET-CT post-surgical resection/prior to CRT, mid-therapy (~4-6 weeks from the start of CRT, and at the end of CRT treatment (~10-14 weeks from the end of treatment).
All the participants that are enrolled in the study will have undergone surgical resection as part of their routine clinical care from which a tissue diagnosis will be confirmed.
On the scan date, the participants will undergo a blood test to measure plasma concentrations of carnitine. During the scan, a single dose of 18F-FPIA (maximum, 370MBq) intravenous (IV) will be administered to the participant followed by a whole brain static PET-CT scan 40 minutes post-injection.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positron Emission Tomography-Computerised Tomography (PET-CT) | Diagnostic Test | Injection of the 18F-fluoropivalate (18F-FPIA) radiotracer followed by a whole brain static PET-CT scan. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of CRT on [18F]-FPIA-detectable fatty acid metabolism | Change in the [18F]FPIA maximum standardised uptake value (SUVmax) & average standardised uptake value (SUVmean) from baseline through the post-treatment PET/CT scan. | Through study completion, an average of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of post-operative residual disease | [18F]FPIA SUVmax & SUVmean at baseline compared to the MRI variables (standardised uptake value (SUV) and lesion-to-grey matter ration [l/g]) measured post-operatively as per standard of care. | Baseline PET/CT scan (~1-4 weeks post-surgical resection) |
| CRT response assessment using [18F]-FPIA PET |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of [18F]-FPIA uptake with available tumour genetics | [18F]-FPIA SUVmax & SUVmean compared with available tumour genetics. | Through study completion, an average of 4 months |
| Correlation of [18F]-FPIA with available standard of care MRI variables |
Inclusion Criteria: Patients with histologically confirmed GBM following surgical resection of their tumour and are eligible for adjuvant chemoradiation with the following characteristics will be recruited:
Exclusion Criteria:
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Patients with histologically confirmed GBM following surgical resection of their tumour and are eligible for adjuvant chemoradiation.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Williams | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | London | United Kingdom |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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The participant will undergo a blood test to measure plasma concentrations of carnitine.
Change in [18F]FPIA SUVmax & SUVmean in patients who ultimately show progressive disease/stable disease/partial response on standard of care imaging. |
| Through study completion, an average of 4 months |
Change in [18F]-FPIA SUVmax & SUVmean compared with available standard of care MRI variables (standardised uptake value (SUV) and lesion-to-grey matter ration [l/g]). |
| Through study completion, an average of 4 months |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |