DCE MRI in Patients With Pancreatic Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 150
Summary
- Conditions
- Hereditary Pancreatic Carcinoma
- Pancreatic Adenocarcinoma
- Pancreatic Intraductal Papillary-Mucinous Neoplasm
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
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 t...
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. SECONDARY OBJECTIVE: I. Clinical factors associated with the presence of pancreatic cancer will be assessed in each of the three experimental groups, including disease free survival and overall survival. II. Additional MRI pulses sequences (e.g. MR fingerprinting, etc.) will be acquired for the assessment of tissue contrast before and after the administration of contrast agents. OUTLINE: Patients are assigned to 1 of 4 groups. ARM I (High-risk for familial or hereditary pancreatic cancer): Patients undergo DCE MRI yearly for a minimum of 3 scans. ARM II (Intraductal papillary mucinous neoplasms [IPMN]): Patients undergo DCE MRI prior to surgery for resection of IPMN. 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. ARM IV (Healthy volunteers): Patients undergo a single DCE MRI examination.
Tracking Information
- NCT #
- NCT02070705
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Oregon Health and Science University
- Investigators
- Principal Investigator: Erin Gilbert OHSU Knight Cancer Institute