NCT03144622Unknown不适用
(4S)-4-(3-[18F]Fluoropropyl)-L-glutamate Radiotracer (FSPG) PET/CT for Imaging xC- Transporter Activity in Cancers
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Staging ability of 18F-FSPG PET/CT
研究概览
简要总结
This study aims to compare the diagnostic performance of 18F-FDG and 18F-FSPG PET/CT in lung, breast, and abdominal cancers before undergoing therapy. In addition, the role of 18F-FSPG PET/CT in evaluating therapy response and prognosis will also be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are given the opportunity to participate in the study if
- •Age ≥ 20 years old.
- •Confirmed diagnosis of primary cancer of the following: NSCLC, breast or abdominal cancers
- •ECOG performance status 0 to
- •Life expectancy > 3 months.
- •Consent to perform additional 18F-FSPG and 18F-FDG PET prior to therapy.
- •Sexually active subjects agree to use condoms and/or their partners of reproductive potential to use a method of effective birth control during imaging period of 2 weeks.
排除标准
- •Patients with any of the following conditions will be excluded
- •Had received previous treatment (excluding neoadjuvant therapy).
- •Pregnant or lactating women.
- •Known malignancy in other organs.
- •Evaluated by primary care physician as unsuitable.
- •Known hypersensitivity to the study drug.
结局指标
主要结局
Staging ability of 18F-FSPG PET/CT
时间窗: 3 years
Sensitivity, specificity, diagnostic accuracy of 18F-FSPG and 18F-FDG PET/CT will be compared according to patient-based and lesion-based analysis using paired t-test or Krusal-Wallis test.
Ability of 18F-FSPG PET/CT in therapy response evaluation and prognosis prediction
时间窗: 3 years
Comparison between 18F-FSPG and 18F-FDG PET/CT will be done using both qualitative and quantitative measures
次要结局
- Safety of 18F-FSPG PET/CT(3 years)
- Uptake of 18F-FSPG(3 years)
研究者
研究点 (1)
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