Borderline Resectable Pancreatic Ductal Adenocarcinoma
Conditions
Brief 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.
Detailed 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, 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.
Interventions
PROCEDUREBiospecimen Collection
Undergo blood sample collection
PROCEDUREComputed Tomography
Undergo CT scan
PROCEDUREDynamic Contrast-Enhanced Magnetic Resonance Imaging
Undergo DCE-MRI
DRUGFluorouracil
Given fluorouracil
Given IV
DRUGGemcitabine
Given gemcitabine
DRUGIrinotecan
Given irinotecan
DRUGLeucovorin Calcium
Undergo leucovorin
DRUGNab-paclitaxel
Given nab-paclitaxel
DRUGOxaliplatin
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.
Sponsors
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 or PET/MRI is NOT acceptable; CT or MRI with contrast as part of PET/CT or PET/MRI is acceptable) of the chest, abdomen, and pelvis, where borderline resectable is defined as all of the following: * Solid tumor involvement of ≤ 180° with the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery). * Solid tumor involvement of \> 180° with the portal vein and/or superior mesenteric vein, and a patent portal vein/splenic vein confluence. * Solid tumor contact with the inferior vena cava. * Absence of metastatic disease * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 for solid tumors within 28 days prior to registration * Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer * Absolute neutrophil count (ANC) ≥ 1.5×109/L (obtained within 28 days prior to registration) * Platelet count ≥ 100,000/mm3 (100 × 109/L) (obtained within 28 days prior to registration) * Hemoglobin (Hgb) ≥ 8 g/dL (obtained within 28 days prior to registration) * Aspartate transaminase (AST), serum glutamic-oxaloacetic transaminase (SGOT), alanine transaminase (ALT), serum glutamic-pyruvic transaminase (SGPT) ≤ 3 × upper limit of normal range (ULN) (obtained within 28 days prior to registration) * Total bilirubin ≤ 2 × ULN (obtained within 28 days prior to registration) * Females of childbearing potential must have a negative pregnancy test (serum or urine) within 3 days prior to registration * Females of childbearing potential must be willing to abstain from vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study, and for 6 months after the last dose of study drug(s). Males must be willing to abstain from vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study, and for 3 months after the last dose of study drug(s) * As determined by the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study * History of HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial * Co-enrollment on a non-interventional therapeutic trial is allowed. This includes observational trials and biomarker collection trials
Exclusion criteria
* 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 * Pregnant or lactating * NOTE: breast milk cannot be stored for future use while the mother is being treated in this study * Patient with any other concurrent severe and/or uncontrolled medical condition that would, in the investigators' judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study, or compromise compliance with the protocol (e.g., chronic active hepatitis, active untreated or uncontrolled fungal, bacterial, or viral infections, etc.) * No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free and treatment-free for at least two years * Patient who is unwilling or unable to comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | At time of surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic contrast enhanced magnetic resonance imaging parameters | At time of surgery | 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. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORHarrison Kim, MBA, PhD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed