MRI with hyperpolarized pyruvate in gliblastoma - a phase II study

Phase 1

Conditions: glioblastoma multiforme, cancer
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-515408-37-00

Lead Sponsor: Aarhus Universitet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

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 Criteria

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, Contraindications to gadolinium contrast o eGFR = 30 mL/min/1.73m2 o Previous adverse reactions to gadolinium, Not able or willing to receive radiotherapy, Predicted remaining survival <3 months, Symptomatic cardiac disease (i.e. valve disease, coronary artery disease, arrythmias etc.). Hypertension and hyperlipidemia are allowed., Subjects who are receiving any other investigational agents., Previous or current treatment by radiation or chemotherapy.