NCT06549413终止不适用
18F-FSPG PET/CT as a Non-Invasive Imaging Biomarker for Treatment Response to Chemoradiation in Esophageal Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
This study is being done to learn how 18F-FSPG PET/CT scan results may be related to the response to chemotherapy and radiation in patients with esophageal cancer.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the ability of 18F-FSPG PET imaging to detect tumors in patients with esophageal cancer.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* ≥ 18 years of age
- •Patients with locally advanced esophageal cancer
- •Patients with untreated documented carcinoma of the esophagus that is > 2 cm who are going to receive systemic therapy concurrently with radiation as primary therapy
- •Ability to provide written informed consent in accordance with institutional policies
- •Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 1 week of the proposed investigational PET/CT scan(s) prior to injection of the investigational radiopharmaceutical
排除标准
- •* Body weight ≥ 400 pounds or body habitus or disability that will not permit the imaging protocol to be performed
- •Pregnant or lactating females
- •Have an allergy to intravenous contrast
- •eGFR < 30
研究组 & 干预措施
Observational
Patients receive 18F-FSPG IV and undergo a PET/CT scan. During week 3 of standard of care radiation therapy, patients receive 18F-FSPG and undergo a second PET/CT scan on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点
研究者
研究点 (1)
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