MRI WITH HYPERPOLARISED PYRUVATE IN GLIOBLASTOMA – A PHASE II STUDY

Christoffer Laustsen0 个研究点目标入组 10 人开始时间: 2020年2月13日最近更新: 2024年7月15日

适应症

试验速览

暂无简介。

•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

•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

发起方

Christoffer Laustsen