MRI WITH HYPERPOLARISED PYRUVATE IN GLIOBLASTOMA – A PHASE II STUDY

Phase 1

Conditions: Glioblastoma multiforme
MedDRA version: 20.0Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Registration Number: EUCTR2020-000310-15-DK

Lead Sponsor: Christoffer Laustsen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

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

•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
oPacemaker, neurostimulator or cochlea implant
oMetal foreign bodies such as fragments and irremovable piercings
oUnsafe medical implants (safety of heart valves, hips and the like must be confirmed)
oIntracranial clips or coils
oClaustrophobia
oLargest circumference including arms > 160 cm
•Contraindications to gadolinium contrast
oeGFR = 30 mL/min/1.73m2
oPrevious adverse reactions to gadolinium
•Not able or willing to receive RCT
•Predicted remaining survival <3 months

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Perfusion (DCE MRI) <br>Microvascular diffusion (ADC MRI)<br>Amide proton transfer weighted (APT) imaging<br>Progression-free survival (PFS) <br>Overall survival (OS)<br>Radiation dose distribution;Timepoint(s) of evaluation of this end point: Variable. Some after the scans, others as they occur (progression, death).