Deuterium Metabolic Imaging to Assess Radiotherapy Changes in Glioblastoma Multiforme
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Deuterium Metabolic Imaging
研究概览
简要总结
This is a feasibility single arm study designed for obtaining early data for optimization and evaluation of the clinical potential for a new MR technique using deuterated glucose. The purpose of the study is to investigate whether this technique 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 treatment response. The study will include 10 patients with histologically verified GBM scheduled for standard RCT. Patients will have MRI scan performed before and within 8 weeks after starting RCT. The scans will include imaging after oral intake of deuterated glucose, so called deuterium metabolic imaging (DMI). Based on this study, the most optimal scanning technique, output variables of highest discriminative power with respect to RCT, and potential predictive markers for response will be selected for further clinical investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed GBM IDHwt
- •Scheduled for long-course radiotherapy
- •At least 18 years of age
- •WHO performance status 0-1
- •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.
- •Danish speaking
- •Able and willing to comply after informed consent
排除标准
- •Subjects who are receiving any other investigational agents.
- •Previous or current treatment by radiation or chemotherapy.
- •History of alcohol abuse or illicit drug use.
- •Contraindications to MRI Pacemaker, neurostimulator or cochlea implant Metal foreign bodies such as fragments and irremovable piercings Unsafe medical implants Intracranial clips or coils Claustrophobia Largest circumference including arms > 160 cm
- •Contraindications to gadolinium contrast eGFR ≤ 30 mL/min/1.73m2 Previous adverse reactions to gadolinium
- •Not able or willing to receive radiotherapy
- •Predicted remaining survival <3 months
- •Insulin-treated diabetes
结局指标
主要结局
Deuterium Metabolic Imaging
时间窗: Imaging repeated twice with ~10 weeks between them.
2H-glucose uptake and conversion to lactate and glx over 120 minutes in normal brain and tumor tissue. Before and after radiochemotherapy to measure the changes with therapy.
次要结局
- Amide proton transfer weighted MRI(Imaging repeated twice with ~10 weeks between them.)
- Perfusion MRI(Imaging repeated twice with ~10 weeks between them.)
- Microvascular diffusion MRI(Imaging repeated twice with ~10 weeks between them.)
- Progression-free survival(Until an event (average 6 months) or closure of the protocol after 4 years.)
- Overall survival(Until an event (average 15 months) or closure of the protocol after 4 years.)