Phase 1-2 18F-FPPRGD2 PET/CT or PET/MRI Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change From Baseline in Maximum Standard Uptake Values (SUVmax)
研究概览
简要总结
The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. The uptake of the novel radiopharmaceutical 18F-FPPRGD2 will be assessed in study participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC) who are receiving antiangiogenesis treatment.
详细描述
PRIMARY OBJECTIVE
• Evaluate 18F-FPPRGD2 and 18F-FDG as PET/CT or PET/MRI radiotracers for imaging prediction and assessment of response to anti-angiogenesis therapy in participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC).
SECONDARY OBJECTIVE
• Progression-free survival (PFS) at up to 1 year after initial scans and treatment
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
All human subject participants were to be evaluated with both 18F-FPPRGD2 PET/CT and 18-FDG PET/CT imaging scans.
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
- •Provides written informed consent
- •Diagnosed with advanced NSCLC, breast cancer, GBM or other cancers (such as head and neck, colorectal, pancreatic, renal cancers); patients will undergo anti-angiogenesis treatment or treatment with other drugs that may alter angiogenesis
- •Able to remain still for duration of each imaging procedure (about one hour)
排除标准
- •Pregnant or nursing
- •Contraindication to MRI
- •History of renal insufficiency (only for MRI contrast administration)
研究组 & 干预措施
Glioblastoma Multiforme (GBM)
Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up)
干预措施: 18F-fludeoxyglucose (18F-FDG) (Drug)
Glioblastoma Multiforme (GBM)
Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up)
干预措施: 18F-FPPRGD2 (Drug)
Gynecological Cancers
Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)
干预措施: 18F-fludeoxyglucose (18F-FDG) (Drug)
Gynecological Cancers
Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)
干预措施: 18F-FPPRGD2 (Drug)
Renal Cell Cancer (RCC)
Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)
干预措施: 18F-fludeoxyglucose (18F-FDG) (Drug)
Renal Cell Cancer (RCC)
Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)
干预措施: 18F-FPPRGD2 (Drug)
结局指标
主要结局
Change From Baseline in Maximum Standard Uptake Values (SUVmax)
时间窗: At baseline and 6 weeks
Maximum standard uptake values (SUVmax) were assessed on the basis of position emission tomography (PET) scans using radiotracers 18F-FPPRGD2 and 18F-FDG at baseline and at regular medical care follow-up (6 to 12 weeks after initiation of treatment). The outcome is assessed as the difference in the maximum standard uptake values (SUVmax) values from baseline to follow-up for the 2 radiotracers, and will be reported for each disease type as the median with standard deviation.
次要结局
- Tumor Response Rate by EORTC Criteria(At baseline and 6 weeks)
- Response Assessment by RANO Criteria(At baseline and 6 weeks)
- Change in Tumor Size(9 to 12 weeks)
- Progression-free Survival (PFS)(1 year)
研究者
Sanjiv Sam Gambhir
Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research
Stanford University