The Use of Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE MRI) in the Management of Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Presence of pancreatic cancer (yes or no) for patients that are either at high risk for hereditary pancreatic cancer (Group I)
研究概览
简要总结
This clinical trial studies an imaging technique known as dynamic contrast enhanced magnetic resonance imaging (DCE MRI) in identifying the presence of pancreatic cancer. DCE MRI is a procedure that takes detailed pictures of functional and structural properties inside the body using magnetic field imaging. These images may better characterize pancreatic cancer in patients at high risk or in patients who may have undergone chemotherapy for pancreatic cancer.
详细描述
PRIMARY OBJECTIVES:
I. Assess the ability of DCE-MRI to identify the presence of pancreatic cancer in patients at high risk for hereditary pancreatic cancer.
II. Assess the ability of DCE-MRI to identify the presence of pancreatic cancer in patients with cystic lesions of the pancreas.
III. Assess the ability of DCE-MRI to accurately predict tumor margins in patients who have undergone chemotherapy for pancreatic cancer.
IV. Obtain DCE-MRI scans of from healthy volunteers (Group 4), to establish baseline imaging parameters of the normal, non-diseased pancreas for use as a comparator to affected pancreata.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ALL PARTICIPANTS: A negative serum or urine pregnancy test for woman of childbearing potential
- •ALL PARTICIPANTS: Ability to understand and the willingness to sign a written informed consent document
- •GROUPS 1, 2, AND 3: "All participants" described above
- •GROUPS 1, 2, AND 3: Must be consented for the Oregon Pancreatic Tumor Registry (OPTR)
- •GROUPS 1, 2, AND 3: Group 1: participants identified as being high-risk for familial or hereditary pancreatic cancer, and must conform to one or more of the following requirements:
- •Have a strong family history of pancreatic cancer; this is defined as pancreatic cancer occurring in one first- degree relative and two other relatives, or two first- degree relatives; or,
- •Have a known high-risk genetic syndrome (e.g., BRCA 1&2, STK11, CDNK2A, PRSS1, and MSH 2&6)
- •GROUPS 1, 2, AND 3: Group 2 participants identified as having IPMN on standard radiographic imaging that meets criteria for resection based on symptoms or on conventional imaging (computed tomography [CT] or MRI) findings
- •GROUPS 1, 2, AND 3: Group 3 participants must have pathologically- confirmed pancreatic adenocarcinoma, with or without the need for neoadjuvant chemotherapy prior to surgical resection.
- •HEALTHY VOLUNTEERS (Group 4): Must meet inclusion criteria for "all participants" described above
- •HEALTHY VOLUNTEERS (Group 4): Group 4 participants must have no history of cancer, pancreatic disease, or family history of pancreatic cancer.
- •Family history will be defined as pancreatic cancer occurring in one first-degree relative and two other relatives, or two first-degree relatives
排除标准
- •Participants unable or unwilling to give written, informed consent or to undergo MRI imaging
- •Participants with multiple drug allergies, and/or subjects who have had an allergic reaction to any intravenous iron replacement product, or a known history of hypersensitivity to ferumoxytol
- •Participants with concurrent clinical diagnosis, evidence of suspected hemochromatosis, or other diseases of iron metabolism (i.e., iron overload)
- •Cirrhosis, cardiomyopathy, restrictive heart disease, or bronzing of the skin
- •Pregnant women are excluded from this study because there is an unknown, but potential risk, for adverse events, as small animal trials have linked ferumoxytol administration (at very high doses) to birth defects (e.g., soft-tissue malformations and decreased fetal weights); it is not known whether ferumoxytol is present in human milk; breastfeeding, however, should be discontinued if the mother receives ferumoxytol while nursing
- •Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol
- •Participants with diagnosis of renal insufficiency or glomerular filtration rate (GFR) < 60 ml/min/1.73m^2
- •Adult patients who require monitored anesthesia for MRI scanning
- •Participants with any contraindications to gadolinium-based contrast agents
- •Participants who have a contraindication for MRI (e.g. metal in their bodies, a cardiac pacemaker, or other incompatible device), or are severely agitated or claustrophobic. (For patients that are eligible but there is a concern of metal in their bodies, the will be given the option if interested to have a x-ray completed prior to study enrollment to determine if they can proceed with the study MRI. Patients with a concern of metal in their bodies that don't agree to a x-ray will not be enrolled into the study.)
研究组 & 干预措施
Arm I (High-risk for familial/hereditary pancreatic cancer)
Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) yearly for a minimum of 3 scans.
干预措施: Dynamic Contrast-Enhanced Magnetic Resonance Imaging (Procedure)
Arm I (High-risk for familial/hereditary pancreatic cancer)
Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) yearly for a minimum of 3 scans.
干预措施: Ferumoxytol (Drug)
Arm II (IPMN)
Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) prior to surgery for resection of IPMN.
干预措施: Dynamic Contrast-Enhanced Magnetic Resonance Imaging (Procedure)
Arm II (IPMN)
Patients undergo DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) prior to surgery for resection of IPMN.
干预措施: Ferumoxytol (Drug)
Arm III (Pancreatic cancer)
Patients who undergo chemotherapy prior to resection will have 2 DCE MRI scans; one study scan prior to undergoing neoadjuvant therapy, as well as one study scan following neoadjuvant therapy as part of their pre-operative work up in addition to the standard imaging studies. For patients that do not require chemotherapy treatment prior to resection they will have just one DCE MRI scan prior to surgical resection. Patients currently undergoing neoadjuvant therapy or who have already completed neoadjuvant therapy that were unable to undergo imaging at baseline and are now proceeding to resection will have one DCE MRI scan prior to surgical resection.
干预措施: Dynamic Contrast-Enhanced Magnetic Resonance Imaging (Procedure)
Arm III (Pancreatic cancer)
Patients who undergo chemotherapy prior to resection will have 2 DCE MRI scans; one study scan prior to undergoing neoadjuvant therapy, as well as one study scan following neoadjuvant therapy as part of their pre-operative work up in addition to the standard imaging studies. For patients that do not require chemotherapy treatment prior to resection they will have just one DCE MRI scan prior to surgical resection. Patients currently undergoing neoadjuvant therapy or who have already completed neoadjuvant therapy that were unable to undergo imaging at baseline and are now proceeding to resection will have one DCE MRI scan prior to surgical resection.
干预措施: Ferumoxytol (Drug)
Arm IV (Healthy volunteers)
Patients undergo a single DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) examination.
干预措施: Dynamic Contrast-Enhanced Magnetic Resonance Imaging (Procedure)
Arm IV (Healthy volunteers)
Patients undergo a single DCE MRI (Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Ferumoxytol) examination.
干预措施: Ferumoxytol (Drug)
结局指标
主要结局
Presence of pancreatic cancer (yes or no) for patients that are either at high risk for hereditary pancreatic cancer (Group I)
时间窗: Up to 5 years
Descriptive statistical analysis will be conducted for primary endpoints.
Presence of pancreatic cancer (yes or no) for patients with cystic lesions of the pancreas (Group II)
时间窗: Up to 5 years
Descriptive statistical analysis will be conducted for primary endpoints.
Change in tumor margins in patients who have undergone chemotherapy for pancreatic cancer (Group III)
时间窗: Baseline to up to 2 years
The change of dynamic contrast enhanced magnetic resonance imaging (DCE MRI) parameters from baseline will be correlated with the tumor margins determined by pathological specimen following surgical resection through linear regression model.
次要结局
- Disease free survival (Group III)(Time of surgical resection to time of recurrence, assessed up to 5 years)
- Disease free survival (Group II)(Time of surgical resection to time of disease recurrence, if applicable, assessed up to 5 years)
- Overall survival (Group I)(Time of surgical resection to time of death, assessed up to 5 years)
- Overall survival (Group II)(Time of surgical resection to time of death, assessed up to 5 years)
- Surgical pathological diagnosis and T & N stage according to the American Joint Committee on Cancer (AJCC) tumor, node, metastasis (TNM) staging system (Group II)(At time of surgery)
- DCE- MRI imaging parameters (Group I)(Up to 5 years)
- DCE- MRI imaging parameters (Group II)(Once prior to surgery)
- DCE- MRI imaging parameters (Group III)(Up to 5 years)
- DCE- MRI imaging parameters and descriptional analysis of normal pancreas DCE- MRI images (Group IV)(Once at time of enrollment)
- Disease free survival (Group I)(Time of enrollment to time of diagnosis, assessed up to 5 years)
- Overall survival (Group III)(Time of surgical resection to time of death, assessed up to 5 years)
- Surgical pathological diagnosis and T & N stage according to the AJCC TNM staging system (Group III)(At time of surgery)
- Resection margin status (R0, R1 or R2) (Group III)(At time of surgery)
研究者
Alexander Guimaraes
Principal Investigator
OHSU Knight Cancer Institute