DCE-MRI to help plan surgery for borderline resectable pancreatic cancer
Official title: DCE-MRI-Informed Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer
Run by Ohio State University Comprehensive Cancer Center · NCT07705919 · Data updated 2026-11-12
This trial tests whether adding DCE-MRI imaging to standard care can better gauge how pancreatic tumors respond to treatment in patients whose cancer might be removable by surgery.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | October 1, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07705919 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically confirmed borderline resectable pancreatic ductal adenocarcinoma, ECOG 0-2, and consent for imaging and biospecimen collection.
✕Probably not a fit
Patients whose tumors do not show imaging changes associated with response or who do not proceed to surgery may not experience a direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study investigates the use of dynamic contrast-enhanced MRI alongside standard clinical assessment to evaluate treatment response in borderline resectable pancreatic ductal adenocarcinoma. Participants receive DCE-MRI before and after initial therapy with either gemcitabine/nab-paclitaxel or FOLFIRINOX-based regimens, with follow-up imaging and CT and blood tests. The primary goal is to see if DCE-MRI information correlates with achieving R0 resection, a complete tumor removal. Secondary aims explore relationships between DCE-MRI parameters and tumor microenvironment features measured by digital histopathology. The study includes biospecimen collection, imaging, and chemotherapy as part of standard care, with imaging used to refine treatment planning prior to surgery.
Why it matters
Potential benefit: If successful, the approach could allow clinicians to better decide which patients are most likely to benefit from surgery after neoadjuvant therapy.
How similar studies have gone: Previous work suggests imaging biomarkers can reflect treatment response in pancreatic cancer, but this specific DCE-MRI approach for BRPC is being evaluated for its added value.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Shafia Rahman, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.