MRI with hyperpolarized pyruvate in gliblastoma - a phase II study
Key facts
- Where
- Aarhus N, DániaSee the site
- Phase
- 2. fázis
Where in Dánia
- Aarhus UniversitetAarhus N, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aarhus Universitet
- Trial code
- EU 2024-515408-37-00
- Record updated
- 2025. november 28.
- Original description
We hypothesis that tumor and therapy related changes in the brain tissue are associated with altered metabolic profiles and this is detectable with hyperpolarized [1-13C]pyruvate MRI.Read full original descriptionShow less
We hypothesis that tumor and therapy related changes in the brain tissue are associated with altered metabolic profiles and this is detectable with hyperpolarized [1-13C]pyruvate MRI.
Inclusion: Patients with newly diagnosed high-grade glioma (grade 3 and 4); Scheduled for radiotherapy; 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.
Exclusion: Not able or willing to receive radiotherapy; Subjects who are receiving any other investigational agents; Previous or current treatment by radiation or chemotherapy; History of alcohol abuse or illicit drug use; Allergy to pyruvate; 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; Symptomatic cardiac disease (i.e. valve disease, coronary artery disease, arrythmias etc.). Hypertension and hyperlipidemia are allowed; Contraindications to gadolinium contrast o eGFR ≤ 30 mL/min/1.73m2 o Previous adverse reactions to gadolinium; Predicted remaining survival <3 months.