FET-PET/MRI Based Treatment Planning for Glioblastoma Multiforme in Post-Surgical Patients (FET-TREAT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Difference in radiation treatment volume as determined by FET-PET/MRI compared to standard of care MRI.
研究概览
简要总结
Glioblastoma multiforme (GBM) represent the most common primary brain malignancy and prognosis remains poor. The most common subtype is glioblastoma which has a 5-year survival rate of approximately 5%. Despite advances in MRI techniques, accurately determining total extent of tumor remains a challenge. The result is incomplete treatment resulting in reduced survival or overtreatment resulting in avoidable treatment related morbidity. A more accurate means of assessing tumor extent is needed to guide management to improve patient survival and quality of life.
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
- •Each participant must meet all of the following inclusion criteria to participate in this study:
- •≥ 18 years of age
- •Diagnosis of glioblastoma multiforme
- •Post-maximally safe surgical resection
- •No prior radiation or systemic treatment for high grade glioma
- •Able to tolerate PET/MRI scan with intravenous contrast
- •Willing to provide informed consent
排除标准
- •All participants meeting any of the following exclusion criteria at baseline screening will be excluded from participation in this study:
- •MRI contraindication
- •Creatinine clearance < 30mL/min
- •Inability to lie still for 60 minutes
- •Gadolinium allergy
- •Positive pregnancy test
- •Breastfeeding
- •Patient unable to follow the protocol for any reason
结局指标
主要结局
Difference in radiation treatment volume as determined by FET-PET/MRI compared to standard of care MRI.
时间窗: 12 months
Volume difference measured in cubic centimetres
次要结局
未报告次要终点
