Pilot Trial of the NK1 Receptor Radio-Ligand [18F]SPA-RQ: Imaging Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Proportion of tumors detected by [18F]-labeled substance P antagonist receptor quantifier positron emission tomography
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using [18F]-labeled substance P antagonist receptor quantifier, may be effective in finding disease in patients with pancreatic cancer.
PURPOSE: This phase I trial is studying how well a PET scan using [18F]-labeled substance P antagonist receptor quantifier works in finding disease in patients with pancreatic cancer.
详细描述
OBJECTIVES:
- Determine whether [18F]-labeled substance P antagonist receptor quantifier positron emission tomography can identify pancreatic cancer evident on multiphase CT scan.
OUTLINE: Patients undergo multiphase CT scan of the chest, abdomen, and pelvis. No more than 15 days later, patients receive [18F]-labeled substance P antagonist receptor quantifier IV and undergo positron emission tomography over 6 hours.
Blood is collected periodically to measure the metabolism of the radiotracer by high performance liquid chromatography with radioactive detectors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Diagnostic
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the pancreas
- •Primary or metastatic disease
- •At least one site of measurable disease
- •Enrolled in an NCI protocol (either a treatment or screening protocol) such as NCI-05-C-0044 or NCI-05-C-0141
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •ECOG performance status 0-2
- •WBC ≥ 1,200/mm³
- •Creatinine < 2.0 mg/dL
- •Negative pregnancy test
- •Fertile patients must agree to use effective contraception
- •Not pregnant or nursing
排除标准
- •Allergy to IV contrast
- •Claustrophobia that would preclude completion of a scan or unable to lie on one's back for positron emission tomography scan
- •PRIOR CONCURRENT THERAPY:
- •Inclusion criteria:
- •More than 4 weeks since prior abdominal surgery
- •Exclusion criteria:
- •Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits
- •Aprepitant within 72 hours of [18F]-labeled substance P antagonist receptor quantifier positron emission tomography
结局指标
主要结局
Proportion of tumors detected by [18F]-labeled substance P antagonist receptor quantifier positron emission tomography
次要结局
未报告次要终点