NCT04410133已完成3 期
An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 19
- 主要终点
- Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level
研究概览
简要总结
An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in detecting recurrent brain metastases after radiation therapy
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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration
- •Previous history of solid tumor brain metastasis of any origin
- •Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years
- •Previous radiation therapy of brain metastatic lesion(s)
- •A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis
- •Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for biopsy/neurosurgical intervention as standard of care (SoC) or clinical follow-up as SoC
排除标准
- •1. Patients with a history of active hematological malignancy
研究组 & 干预措施
Patients
Experimental
Single intravenous administration of 18F fluciclovine for PET Scan
干预措施: 18F fluciclovine (Drug)
结局指标
主要结局
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level
时间窗: MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.
Subject-level PPA and NPA (equivalent to sensitivity and specificity, respectively) of 18F-fluciclovinePET in detecting recurrent brain metastases.
次要结局
- Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)(MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.)
- Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)(MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.)
- Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)(MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.)
- Subject-level Positive Percent Agreement (PPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type(MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.)
- Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type(MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.)
- Subject-level Positive Percent Agreement (NPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy(MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.)
- Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy(MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.)
- Clinical Usefulness(Follow up through 6 months after PET scan.)
- Inter-reader Reproducibility(PET Scan Day 1)
- Intra-reader Reproducibility(PET Scan Day 1)
- Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure(The vital signs collected between 5 to 60 minutes before and after the PET scan.)
- Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate(The vital signs collected between 5 to 60 minutes before and after the PET scan.)
- Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate(The vital signs collected between 5 to 60 minutes before and after the PET scan.)
- Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature(The vital signs collected between 5 to 60 minutes before and after the PET scan.)
研究者
研究点 (19)
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