Glioblastoma multiforme MedDRA version: 20.0 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Christoffer Laustsen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with newly diagnosed GBM, IDH wt • Scheduled for RCT • At least 18 years of age • WHO performance status 0-2 • 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. If the partner is non fertile or the patient has no sexual activities, this is also accepted. • Danish speaking • Able and willing to comply after informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: • Subjects who are receiving any other investigational agents. • Previous or current treatment by radiation or chemotherapy. • IDH mutant • History of alcohol abuse or illicit drug use. • Contraindications to MRI o Pacemaker, neurostimulator or cochlea implant o Metal foreign bodies such as fragments and irremovable piercings o Unsafe medical implants (safety of heart valves, hips and the like must be confirmed) o Intracranial clips or coils o Claustrophobia o Largest circumference including arms > 160 cm • Contraindications to gadolinium contrast o eGFR = 30 mL/min/1.73m2 o Previous adverse reactions to gadolinium • Not able or willing to receive RCT • Predicted remaining survival <3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the study is to investigate whether MRI with Hyperpolarized pyruvate 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 response. ;Secondary Objective: Nor applicable;Primary end point(s): [1-13C]pyruvate perfusion, uptake and conversion to [1-13C]lactate, [1-13C]alanine and [13C] bicarbonate in normal brain and tumor tissue;Timepoint(s) of evaluation of this end point: After the second scan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Perfusion (DCE MRI) Microvascular diffusion (ADC MRI) Amide proton transfer weighted (APT) imaging Progression-free survival (PFS) Overall survival (OS) Radiation dose distribution;Timepoint(s) of evaluation of this end point: Variable. Some after the scans, others as they occur (progression, death). | — |
Countries
Denmark
Contacts
Public ContactMR Research Centre
Aarhus University
Outcome results
None listed