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.
PRIMARY OBJECTIVE: I. To evaluate the association between the availability of DCE-MRI-derived information and R0 resection rates in patients with BRPC, compared to standard-of-care management. SECONDARY OBJECTIVE: I. To assess the association between DCE-MRI parameters and tumor microenvironment features measured by digital histopathology. OUTLINE: Within two weeks prior to therapy initiation, patients receive gadolinium based contrast intravenously (IV) and undergo DCE-MRI. Patients then undergo standard of care treatment with gemcitabine and nab paclitaxel or fluorouracil, oxaliplatin, irinotecan and leucovorin, per the treating gastroenterology oncologist. Approximately 6 weeks after therapy initiation and again within 1 week prior to surgery, patients receive gadolinium based contrast IV and undergo DCE-MRI again. Patients undergo computed tomography (CT) scan and blood sample collection throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
Undergo blood sample collection
Undergo CT scan
Undergo DCE-MRI
Given fluorouracil
Given IV
Given gemcitabine
Given irinotecan
Undergo leucovorin
Given nab-paclitaxel
Given oxaliplatin
The 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.
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
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.
Time frame: At time of surgery
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.
Time frame: At time of surgery
The Ohio State University Comprehensive Cancer Center
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