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This is a feasibility single arm study designed for obtaining early data for optimization and evaluation of the clinical potential for a new MR technique using deuterated glucose. The purpose of the study is to investigate whether this technique is useful in metabolic imaging of glioblastoma multiforme (GBM) and whether radiochemotherapy (RCT) induced changes in the brain metabolism can be detected and might be predictive for treatment response. The study will include 10 patients with histologically verified GBM scheduled for standard RCT. Patients will have MRI scan performed before and within 8 weeks after starting RCT. The scans will include imaging after oral intake of deuterated glucose, so called deuterium metabolic imaging (DMI). Based on this study, the most optimal scanning technique, output variables of highest discriminative power with respect to RCT, and potential predictive markers for response will be selected for further clinical investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GBM patients, IDH-wt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deuterium metabolic imaging | Diagnostic Test | MRI after oral administration of 75g of [6,6'-2H2]glucose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Deuterium Metabolic Imaging | 2H-glucose uptake and conversion to lactate and glx over 120 minutes in normal brain and tumor tissue. Before and after radiochemotherapy to measure the changes with therapy. | Imaging repeated twice with ~10 weeks between them. |
| Measure | Description | Time Frame |
|---|---|---|
| Perfusion MRI | Dynamic contrast enhancement MRI using a gadolinium-based contrast agent. | Imaging repeated twice with ~10 weeks between them. |
| Microvascular diffusion MRI | Diffusion-weighted MRI. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with newly diagnosed GBM, idh-wt (performance 0-1) are enrolled before initiating radiochemotherapy. They are not allowed to have contraindications to MRI with contrast or diabetes.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University | Aarhus | 8200 | Denmark |
Data will be shared in anonymized form if the local juridical office accepts that full anonymization can be achieved.
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| Imaging repeated twice with ~10 weeks between them. |
| Amide proton transfer weighted MRI | APT-CEST MRI. | Imaging repeated twice with ~10 weeks between them. |
| Progression-free survival | Time until progression or death. | Until an event (average 6 months) or closure of the protocol after 4 years. |
| Overall survival | Time until death. | Until an event (average 15 months) or closure of the protocol after 4 years. |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |