This clinical trial tests how well dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) with standard clinical evaluation works to assess treatment response for patients with pancreatic cancer that may be able to be removed by surgery (borderline resectable). Borderline resectable pancreatic cancer (BRPC) is a certain type of pancreatic cancer that involves the arteries or veins near the pancreas. With the right treatment before surgery, it can be removed (resected) successfully. An MRI (magnetic resonance imaging) scan creates clear images of the structures inside the body using a large magnet, radio waves, and a computer. DCE-MRI can be used to calculate the blood perfusion. Blood perfusion can show disease status. Using DCE-MRI as part of standard clinical evaluation may provide a more accurate treatment response assessment for patients with BRPC.
Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
Age ≥ 18 years at the time of consent
Patients have Eastern Cooperative Group (ECOG) performance status of 0-2
Histological or cytological evidence of pancreatic adenocarcinoma
Evidence of distant metastasis
History of significant uncontrolled cardiovascular disease. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation, or dyspnea)
History of arrhythmia that is symptomatic or requires treatment. However, patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial
Patient with a history of allergy or hypersensitivity to any of the study drugs or any of their excipients
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT scan
Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Procedure/SurgeryUndergo DCE-MRI
Fluorouracil
DrugGiven fluorouracil
Gadolinium-Chelate
DrugGiven IV
Gemcitabine
DrugGiven gemcitabine
Irinotecan
DrugGiven irinotecan
Leucovorin Calcium
DrugUndergo leucovorin
Nab-paclitaxel
DrugGiven nab-paclitaxel
Oxaliplatin
DrugGiven oxaliplatin
Point-of-care portable perfusion phantom (P4)
DeviceThe Point-of-care Portable Perfusion Phantom (P4) is a small, non-invasive calibration device developed to support quality assurance of quantitative magnetic resonance imaging (MRI). The device is designed to reproduce controlled imaging properties comparable to those observed in human tissue, allowing assessment of scanner performance during image acquisition.
R0 resection rate
Will be calculated as the proportion of patients achieving R0 resection among evaluable participants, along with a 90% confidence interval based on the binomial distribution. Comparisons of R0 resection rates between the prospective cohort and the matched control group will be conducted using Fisher's exact test.
Dynamic contrast enhanced magnetic resonance imaging parameters
Will be compared with histopathologic findings in resected tumors. Associations between imaging parameters and tumor regression scores will be evaluated using graphical methods and Spearman correlation analysis.
Click on the lead sponsor to view all of their trials.
Ohio State University Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
