NCT06305728招募中不适用
Immuno-Positron Emission Tomography, Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients With Intraductal Papillary Mucinous Neoplasms
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 16
- 主要终点
- Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma
研究概览
简要总结
The purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/PDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts:
- The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1
- The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan)
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
- •Men and women aged >18 years
- •Pancreatic cystic neoplasm deemed to be high risk and requiring surgical resection
- •Able to provide informed consent
排除标准
- •Pathologic evidence of pancreatic cancer
- •Pregnant or breast-feeding patients
- •Refusal or inability to tolerate scan (eg anxiety or claustrophobia)
- •Inability to lay flat or meet the standard requirements of traditional MRI
- •Hepatic function from assays obtained within 6 weeks prior to the study enrollment. For each patient, the upper limit of normal (ULN) value for a particular assay will be defined by the normal reference values of the laboratory that performed the assay
- •Bilirubin > 1.5 x ULN
- •AST/ALT > 2.5 x ULN
- •Albumin < 3 g/dL
- •GGT > 2.5 x ULN if Alkaline Phosphatase > 2.5 x ULN
- •Renal function with Creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min, from assays obtained within 6 weeks prior to study enrollment
- •Cardiac: congestive heart failure with New York Heart Association (NYHA) status ≥2, poorly controlled hypertension, a history of clinically significant EKG abnormalities, or myocardial infarction within 6 months of study enrollment.
结局指标
主要结局
Sensitivity of ImmunoPET to identify presence or absence of adenocarcinoma
时间窗: up to 1 year
Assess preliminary sensitivity and specificity if the immunoPET is able to identify the presence or absence of adenocarcinoma or high-grade dysplasia in participants who are scheduled to undergo surgical resection.
次要结局
未报告次要终点
研究者
研究点 (16)
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