Assessment of Early Post-operative Nuclear Imaging in Neurosurgery: a Safety and Feasibility Study in Patients Operated for Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Assess the safety of performing early post-operative brain PET-MRI in neurosurgery patients
研究概览
简要总结
This clinical trial aims to evaluate the feasibility and safety of early post-operative brain PET-MRI imaging in adult patients who have undergone surgery for suspected glioblastoma. The study also seeks to validate specific nuclear imaging parameters for better detection of residual tumor tissue compared to standard gadolinium-enhanced MRI. The main objectives are to determine whether early PET-MRI within 48 hours post-surgery is feasible, to assess potential side effects related to imaging procedures, and to explore if PET parameters such as SUVmax, metabolic volume, and tumor-to-striatum ratio can improve the detection of tumor residue. A total of 15 patients will be included at a single site in France. Participants will undergo PET-MRI using 18F-DOPA and gadolinium, and will be monitored for radiation exposure and possible adverse events up to 24 hours after imaging.
详细描述
This study aims to assess safety and feasibility of early post-operative PET-MRI and validate imaging parameters for detecting glioblastoma residue, enabling future personalized post-surgical care.
The primary objectives are to :
- Asses the safety of performing early post-operative brain PET-MRI in neurosurgery patients after glioblastoma surgery.
- Measure the nuclear exposition of patients when performing early post-operative brain PET-MRI in neurosurgery patients.
- Assess the feasibility of performing early post-operative brain PET-MRI in neurosurgery patients.
It is a prospective interventional diagnostic study involving patient comparison Category RIPH. 15 patients will be included. This is a monocentric study. One surgical and including site (CHU Henri Mondor), in one country (France).
Patients will participate during 24 hours. The duration of the study is 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •First resection for a suspected glioblastoma in the past 72h
- •Signed informed consent
- •non-inclusion Criteria:
- •Deprived of liberty or under legal protection (e.g, guardianship, trusteeship)
- •Patients under 18 years old
- •Absence of social security cover
- •Pregnancy
- •Emergency procedure
- •Contraindication to brain MRI, including claustrophobia
- •Contraindication to radiotracers or gadolinium injection
- •Preoperative cognitive impairment impeding patient information
排除标准
- •Any postoperative behavioral disorders or medical condition or symptom impeding the completion of brain imaging
- •Postoperative medical dependency impeding the patient transfer to the nuclear medicine department (including, but not limited to, invasive ventilation, need for external ventricular drainage…)
- •Postoperative histological diagnosis different from glioblastoma
研究组 & 干预措施
Early post-operative PET-MRI group
Participants in this arm will undergo early post-operative PET-MRI imaging within 48 hours after surgical resection of a suspected glioblastoma. The imaging procedure includes a brain MRI with gadolinium-based contrast and a PET scan using 18F-DOPA as the radiotracer. Patients will be monitored for potential adverse events related to the imaging agents and for radiation exposure. No therapeutic intervention will be administered. The purpose of this diagnostic intervention is to assess feasibility, safety, and imaging performance in detecting residual tumor tissue.
干预措施: Early post-operative brain PET-MRI with 18F-DOPA and Gadolinium (Diagnostic Test)
结局指标
主要结局
Assess the safety of performing early post-operative brain PET-MRI in neurosurgery patients
时间窗: Within 24 hours after surgery
by collecting side effects associated with radiotracer injection and imaging procedure after surgery during the inclusion period
Assess the safety of performing early post-operative brain PET-MRI in neurosurgery patients
时间窗: Whithin 24 hours after surgery
by measuring ambient gamma dose rate at several time points (Hour 0, Hour 1, Hour 2, Hour 4 et Hour 24) on different points according to appendix.
Assess the safety of performing early post-operative brain PET-MRI in neurosurgery patients
时间窗: Whithin 24 hours afin surgery
by measuring ambient gamma dose rate at several time points on different points (on the patient, 50 centimeters, 1 meter, 2 meters from the patient) according to appendix.
Assess the feasibility of performing early post-operative brain PET-MRI in neurosurgery patients
时间窗: Within 24 hours after surgery
by recording the rate of patients excluded after inclusion for non-realized imaging or incomplete imaging, at the physician's or the patient's demand.
次要结局
- Validate a nuclear imaging protocol to measure residual tumor volume on early post-operative brain PET-MRI in neurosurgery patients(24 hours)
- Evaluate the inter-raters reliability of nuclear imaging protocol (T/S and T/CC) to evaluate the presence or absence of residual tumor on early post-operative brain PET in neurosurgery patients.(24 hours)
- Evaluate the inter-raters reliability of nuclear imaging protocol (metabolic volume with different thresholds) to measure residual tumor volume on early post-operative brain PET in neurosurgery patients.(24 hours)