A Pilot Study to Evaluate Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Preoperative [Cu64]DOTATATE PET SUV
研究概览
简要总结
The study team hypothesizes that it is feasible to intraoperatively detect tumor following [CU64]DOTATATE injection using the gamma probe device.
详细描述
Objectives:
Primary objectives: The primary objective of this pilot study is to evaluate the feasibility of intraoperative tumor detection using [Cu64]DOTATATE. The study team further wants to validate the gamma count measurements using pre- and post-operative Positron Emission Tomography (PET) standardized uptake value (SUV) .
Secondary Objectives: To correlate intraoperative tracing findings with from pathology markers ( World Health Organization grade (WHO grade), Ki-67, Somatostatin Receptor 2 expression (SSTR2A expression), Estrogen receptor expression (ER expression), Progesterone receptor expression (PR expression)) using samples obtained as part of routine surgical care. To evaluate the correlation of post resection gamma count with longitudinal PET follow up.
Exploratory objectives: To establish best practices for integration of intraoperative tumor tracing using the neoprobe into the surgical workflow. To determine surgical candidates who will benefit most from intraoperative tracing based on tumor location, MRI features, etc.
Overall Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High suspicion of meningioma necessitating surgical resection based on conventional MRI criteria, or diagnosis of meningioma based on pathology reports from prior resection with radiographic findings of suspected recurrent or residual tumor necessitating repeat surgery.
排除标准
- •Pregnant or breastfeeding
- •Patients undergoing endoscopic endonasal resection, eyebrow incision surgery, or any surgical procedure in which the neoprobe cannot be employed
- •Patients with hypersensitivity to somatostatin analogs
- •Patients with contraindications to conventional MRI
- •Patients with prior history of cranial radiation therapy
- •Patients currently enrolled in other therapeutic clinical trials related to meningioma will be excluded
结局指标
主要结局
Preoperative [Cu64]DOTATATE PET SUV
时间窗: At time of enrollment
preoperative lesion \[Cu64\]DOTATATE PET SUV
MRI Size Measurements
时间窗: At time of enrollment
preoperative size measurements based on Response Assessment in Neuro-Oncology (RANO) guidelines
1st Post-operative [Cu64]DOTATATE PET SUV
时间窗: 3 months
6 weeks to 3 months follow up post operative \[Cu64\]DOTATATE PET SUV
2nd Post-operative [Cu64]DOTATATE PET SUV
时间窗: 1 year
6 months to 12 months follow up post operative \[Cu64\]DOTATATE PET SUV
GTR vs STR Assessment
时间窗: 6 weeks- 3 months
postoperative MRI-based assessment of GTR versus STR by a neuroradiologist, as determined by the presence or absence of nodular dural-based enhancement on post contrast 3D T1-weighted MR imaging and direct comparison to preoperative MRI.
MRI Progression Assessment
时间窗: 6-12 months
follow-up MRI assessment of progression based on RANO guidelines
Target Lesion Neoprobe Count
时间窗: At time of enrollment
Neoprobe count of the target lesion prior to resection.
Subtotal Neoprobe Count
时间窗: At time of enrollment
Neoprobe count of the subtotally resected tumor or the resection cavity in case of presumed GTR post resection.
Reference Background Neoprobe Count
时间窗: At time of enrollment
Neoprobe count of the reference background measured at least 1 cm away from the tumor (measured in at least two locations depending on the operative field)
次要结局
- SSTR2 expression(At time of clinical neuropathological evaluation of resected tumor tissue (Immediate postoperative setting).)
- WHO grade(At time of clinical neuropathological evaluation of resected tumor tissue (Immediate postoperative setting).)
- Ki67 Proliferation Index(At time of clinical neuropathological evaluation of resected tumor tissue (Immediate postoperative setting).)
- ER/PR expression(At time of clinical neuropathological evaluation of resected tumor tissue (Immediate postoperative setting).)