An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
研究概览
简要总结
The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers.
详细描述
OUTLINE:
Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG [18F-(S)-4-(3-fluoropropyl)-L-glutamic acid] or 18F-FDG ([18F]-fluorodeoxyglucose), before and after therapeutic treatment.
PRIMARY OBJECTIVE:
Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients.
SECONDARY OBJECTIVES:
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
- •Written informed consent
- •Able to complete a PET/CT scan without the use of sedation
- •Of childbearing potential must:
- •Not be nursing
- •Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT
- •Not of childbearing potential must be:
- •Physiologically postmenopausal (cessation of menses for more than 1 year)
- •Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy)
- •Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent
- •Scheduled to begin therapy
- •The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options)
- •Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT scheduled or performed (exceptions by investigator discretion)
- •No clinically relevant deviations in renal function (serum creatinine > grade 2 Common Terminology Criteria for Adverse Events [CTCAE] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week
排除标准
- •Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration
- •Known sensitivity to 18F FSPG or components of the preparation
- •Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety
研究组 & 干预措施
18F-FSPG and 18F-FDG Intragroup Comparision
Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.
干预措施: 18F-FSPG (Drug)
18F-FSPG and 18F-FDG Intragroup Comparision
Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.
干预措施: 18F-FDG (Drug)
结局指标
主要结局
Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
时间窗: Baseline and up to 2 years
Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.
次要结局
- Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs(Baseline and up to 2 years)
- Number of Treatment-Related Adverse Events(Baseline to up to 2 years)
研究者
Andrei Iagaru
Associate Professor of Radiology
Stanford University