Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deuterium metabolic imaging.
- Who it may be relevant to
- Registry conditions: Glioblastoma Multiforme. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Deuterium metabolic imaging
MRI after oral administration of 75g of \[6,6'-2H2\]glucose.
Primary outcome measures
- Deuterium Metabolic Imaging [Time frame: Imaging repeated twice with ~10 weeks between them.]
Secondary outcome measures (5)
- Perfusion MRI [Time frame: Imaging repeated twice with ~10 weeks between them.]
- Microvascular diffusion MRI [Time frame: Imaging repeated twice with ~10 weeks between them.]
- Amide proton transfer weighted MRI [Time frame: Imaging repeated twice with ~10 weeks between them.]
- Progression-free survival [Time frame: Until an event (average 6 months) or closure of the protocol after 4 years.]
- Overall survival [Time frame: Until an event (average 15 months) or closure of the protocol after 4 years.]
Eligibility criteria
Inclusion criteria
- Patients with newly diagnosed GBM IDHwt
- Scheduled for long-course radiotherapy
- At least 18 years of age
- WHO performance status 0-1
- Women who are not postmenopausal or surgically sterile must have a negative serum or urine pregnancy test performed at time of inclusion in the study. Safe and highly effective contraception must be used throughout the study meaning either hormonal anti-conception or an anti-fertility intrauterine device.
- Danish speaking
- Able and willing to comply after informed consent
Exclusion criteria
- Subjects who are receiving any other investigational agents.
- Previous or current treatment by radiation or chemotherapy.
- History of alcohol abuse or illicit drug use.
- Contraindications to MRI Pacemaker, neurostimulator or cochlea implant Metal foreign bodies such as fragments and irremovable piercings Unsafe medical implants Intracranial clips or coils Claustrophobia Largest circumference including arms > 160 cm
- Contraindications to gadolinium contrast eGFR ≤ 30 mL/min/1.73m2 Previous adverse reactions to gadolinium
- Not able or willing to receive radiotherapy
- Predicted remaining survival <3 months
- Insulin-treated diabetes
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Aarhus University — Aarhus
Identifiers
NCT: NCT05908669 · DMI-GBM