DCE-MRI-Informed Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer
Ohio State University Comprehensive Cancer Center
Summary
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.
Description
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,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Patients must have borderline resectable primary tumor per National Comprehensive Cancer Network (NCCN) definitions version 2.2025 based on contrast-enhanced CT or MRI (CT or MRI without contrast as part of positron emission tomography \[PET\]/CT…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT scan
- ProcedureDynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE-MRI
- DrugFluorouracil
Given fluorouracil
- DrugGadolinium-Chelate
Given IV
- DrugGemcitabine
Given gemcitabine
- DrugIrinotecan
Given irinotecan
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio