Evaluation of the Novel Imaging Modality Simultaneous Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI) in Patients With Pancreatic Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- PET/MRI compared to conventional CT and MRI
研究概览
简要总结
This study will use PET/MRI in patients with adenocarcinoma of the pancreas to identify hidden metastatic disease or identify patients with borderline or locally advanced disease.
详细描述
Patients will receive a PET/MRI scan within 6 weeks of their standard of care imaging. There is no maximum number of scans for research. The number of scans depends on each patient's treatment plan.
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
- •Presence of suspicious lesion of the pancreas consistent with pancreatic adenocarcinoma. Cytological confirmation is not required.
- •Patients preparing to receive therapy for pancreas cancer, including patients enrolled in NCT01413022
- •Patient must be 18 years or older
- •Patient must have a life expectancy of more than 6 months and performance status of 2 or less
- •Patient must be able to understand and willing to sign an approved written informed consent document
- •Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the length of the study
- •Patients enrolled in the Clinical trials.gov# NCT01413022 trial must meet both studies eligibility criteria.
排除标准
- •Patient must not have had prior resection for pancreatic adenocarcinoma.
- •Patient must not have a history of other malignancy less than or equal to 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix
- •Patient must not be unable to receive a PET-MRI scan due to renal function, allergy or other problem with receiving or tolerating an MRI scan, etc. All patients will fill out a standard MRI screening form.
- •Patients must not have a blood glucose of greater than or equal to 200mg/dL at the time of PET-MRI or if a patient is diabetic and glucose is not controlled. At the discretion of the PI and the authorized user and with their approval prior to 2-[18]fluoro-2-deoxy-D-glucose (FDG) injection, patients with blood glucose ≥ 200 mg/dL may participate in the study.
- •Patient must not be pregnant and/or breast feeding
研究组 & 干预措施
Imaging
PET/MRI
干预措施: PET/MRI (Procedure)
结局指标
主要结局
PET/MRI compared to conventional CT and MRI
时间窗: Up to several months or longer. Patient will undergo research imaging with each standard of care scan they have.
Primary outcome is to determine if the primary tumor and the margins of anatomical land marks from the PET/MRI imaging is more precise and gives a clearer picture of tumor location than standard care, CT or MRI. Both standard of care imaging and this new technology will be compared to the final pathologic analysis, measuring the true distance (in mm) between the primary tumor and margins. Data will be reported as mm.
次要结局
- Resectability post neoadjuvant treatment(Several months or as deemed a surgical candidate by physician.)