SSTR2-Targeted PET Imaging of Meningioma: Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Qualitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.
研究概览
简要总结
The goal of this study is to propose the first direct comparison of Ga-68-DOTATATE PET/CT or PET/MR and Ga-68-DOTATOC PET/CT in patients with meningioma.
详细描述
The investigator is proposing a direct comparison of Ga-68-DOTATATE and -DOTATOC in a pilot cohort of patients with meningioma, and hypothesize non-inferiority of DOTATOC. This pilot study will form the basis for a subsequent prospective clinical trial and will allow us to optimize our existing imaging protocols, while developing a more cost-effective protocol.
Primary Objectives:
- Optimize the Ga-68-DOTATOC PET/CT protocol.
- Compare Ga-68-DOTATATE PET and -DOTATOC PET/CT in patients with meningioma.
Secondary Objectives
• Correlate Ga-68-DOTATATE PET and -DOTATOC PET/CT with clinical and pathological characteristics
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with clinically suspected meningioma
- •Patients planned for surgery - undergoing preoperative workup
- •No contraindications to either radiotracer
排除标准
- •Age less than 18 years
- •Inability to lay on the scanner table for the required period of time, e.g., due to bone pain or claustrophobia.
研究组 & 干预措施
Patients with Meningioma
Subjects with suspected meningioma planned for surgery who meet the inclusion and exclusion criteria.
干预措施: Ga-68- DOTATATE (Drug)
Patients with Meningioma
Subjects with suspected meningioma planned for surgery who meet the inclusion and exclusion criteria.
干预措施: Ga-68-DOTATOC (Drug)
结局指标
主要结局
Qualitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.
时间窗: Over 12 months
Compare visual appearance qualitatively using the maximum SUV ratio of target lesion to cranial blood pool (i.e. superior sagittal sinus reference region) of DOTATATE and DOTATOC PET scans in patients with meningioma. Based on our pilot clinical case series, the following reference regions will be evaluated: 1. Suspected meningioma; 2. Pituitary gland; 3. Superior sagittal sinus; 4. Brain parenchyma. Dynamic PET will be acquired and data will be analyzed including comparison of tissue-activity curves and Patlak analysis, as established by the PI in a pilot cohort. Extent of meningioma based on Ga-68-DOTATATE- and DOTATOC PET/CT will be compared to extent of disease as determined by MRI.
Quantitatively measure the visual appearance of target lesion to cranial blood pool using the maximum SUV ratio to compare results from Ga-68-DOTATATE and -DOTATOC PET.
时间窗: Over 12 months
Compare visual appearance quantitatively using the maximum SUV ratio of target lesion to cranial blood pool (i.e. superior sagittal sinus reference region) of DOTATATE and DOTATOC PET scans in patients with meningioma. Qualitative analysis will include evaluation by board certified radiologists with expertise in nuclear medicine/ molecular imaging who will be blinded to the radiotracer injected. Quantitative analysis will include extraction of the ratio of lesion's SUVmax values/reference regions.
次要结局
- Compare molecular biomarker (Ki67) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (Ki67) results to the maximum SUV ratio of target lesion to cranial blood pool.(Over 12 months)
- Compare molecular biomarker (EGFR) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (EGFR) results to the maximum SUV ratio of target lesion to cranial blood pool.(Over 12 months)
- Compare molecular biomarker (progesterone receptor) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (progesterone receptor) results to the maximum SUV ratio of target lesion to cranial blood pool.(Over 12 months)
- Compare molecular biomarker (SSTR2 expression) analysis to Ga-68-DOTATATE PET and Ga-68-DOTATOC PET by measuring biomarker histopathology (SSTR2 expression) results to the maximum SUV ratio of target lesion to cranial blood pool.(Over 12 months)