Pyruvic acid for Glioblastoma multiforme | Cancer

Inclusion criteria

• {"criterion_text":"- Patients with newly diagnosed high-grade glioma (grade 3 and 4)\n- Scheduled for radiotherapy\n- At least 18 years of age\n- WHO performance status 0-2\n- 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.\n- Danish speaking\n- Able and willing to comply after informed consent"}

Exclusion criteria

• {"criterion_text":"- History of alcohol abuse or illicit drug use.\n- Allergy to pyruvate\n- 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\n- Contraindications to gadolinium contrast o eGFR ≤ 30 mL/min/1.73m2 o Previous adverse reactions to gadolinium\n- Not able or willing to receive radiotherapy\n- Predicted remaining survival <3 months\n- Symptomatic cardiac disease (i.e. valve disease, coronary artery disease, arrythmias etc.). Hypertension and hyperlipidemia are allowed.\n- Subjects who are receiving any other investigational agents.\n- Previous or current treatment by radiation or chemotherapy."}

Primary endpoints

• {"endpoint_text":"- [1-13C]pyruvate perfusion, uptake and conversion to [1-13C]lactate, [1-13C]alanine and [13C] bicarbonate in normal brain and tumor tissue","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Perfusion (DCE MRI)\n- Microvascular diffusion (ADC MRI)\n- Amide proton transfer weight (APT) imaging\n- Progression-free survival (PFS)\n- Overall survival (OS)\n- Radiation dose distribution","definition_or_measurement_approach":"Perfusion measured by DCE MRI; Microvascular diffusion measured by ADC MRI; APT imaging measured by APT imaging; PFS and OS are standard survival endpoints; Radiation dose distribution as recorded in radiation planning/delivery (no further detail provided)."}

Denmark

Earliest CTIS Part Ii Submission Date

02-07-2024

Latest Decision Or Authorization Date

10-07-2024

Processing Time Days

8

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Aarhus Universitet

Organisation Type

Educational Institution

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code 1","organisation_type":"Educational Institution"}