DCE-MRI for Neoadjuvant Treatment Assessment in Patients With Borderline Resectable Pancreatic Cancer

DCE-MRI-Informed Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Borderline Resectable Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Gadolinium-Chelate; Drug: Irinotecan; Drug: Leucovorin Calcium; Device: Point-of-care portable perfusion phantom (P4)

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
      • Contact: Harrison Kim, MBA, PhD; Phone Number: 614-814-1590; Email: Harrison.Kim@osumc.edu
      • Principal Investigator: Harrison Kim, MBA, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (DCE-MRI); Within two weeks prior to therapy initiation, patients receive gadolinium based contrast 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 CT scan and blood sample collection throughout the study.

Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Sample Collection; Procedure: Computed Tomography; Undergo CT scan; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Computerized axial tomography (procedure); Computerized Tomography (CT) scan; Diagnostic CAT Scan; Diagnostic CAT Scan Service Type; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Undergo DCE-MRI; Other Names: DCE-MRI; DCE MRI; DYNAMIC CONTRAST ENHANCED MRI; DCE; Drug: Nab-paclitaxel; Given nab-paclitaxel; Other Names: ABI-007; Abraxane; Albumin-bound Paclitaxel; ABI 007; Albumin-Stabilized Nanoparticle Paclitaxel; Nanoparticle Albumin-bound Paclitaxel; Nanoparticle Paclitaxel; Paclitaxel Albumin; paclitaxel albumin-stabilized nanoparticle formulation; Protein-bound Paclitaxel; ABI007; Paclitaxel Protein-Bound; Paclitaxel Nanoparticle Albumin-bound; Naveruclif; Drug: Gemcitabine; Given gemcitabine; Other Names: dFdCyd; dFdC; Difluorodeoxycytidine; Drug: Oxaliplatin; Given oxaliplatin; Other Names: 1-OHP; Dacotin; Dacplat; Eloxatin; Ai Heng; Aiheng; Diaminocyclohexane Oxalatoplatinum; Eloxatine; JM-83; Oxalatoplatin; Oxalatoplatinum; RP 54780; RP-54780; SR-96669; SR96669; Elplat; JM 83; JM83; RP54780; SR 96669; Drug: Fluorouracil; Given fluorouracil; Other Names: 5-Fluracil; Fluracil; 5 Fluorouracil; 5 Fluorouracilum; 5 FU; 5-Fluoro-2,4(1H, 3H)-pyrimidinedione; 5-Fluorouracil; 5-Fu; 5FU; AccuSite; Carac; Fluoro Uracil; Fluouracil; Flurablastin; Fluracedyl; Fluril; Fluroblastin; Ribofluor; Ro 2-9757; Ro-2-9757; Drug: Gadolinium-Chelate; Given IV; Other Names: Gadolinium Coordination Complex; Gadolinium-based Contrast Agent; Gadolinium-Chelant Complex; Drug: Irinotecan; Given irinotecan; Drug: Leucovorin Calcium; Undergo leucovorin; Other Names: Wellcovorin; folinic acid; Adinepar; Calcifolin; Calcium (6S)-Folinate; Calcium Folinate; Calcium Leucovorin; Calfolex; Calinat; Cehafolin; Citofolin; Citrec; Citrovorum Factor; Cromatonbic Folinico; Dalisol; Disintox; Divical; Ecofol; Emovis; Factor, Citrovorum; Flynoken A; Folaren; Folaxin; FOLI-cell; Foliben; Folidan; Folidar; Folinac; Folinate Calcium; Folinic Acid Calcium Salt Pentahydrate; Folinoral; Folinvit; Foliplus; Folix; Imo; Lederfolat; Lederfolin; Leucosar; leucovorin; Rescufolin; Rescuvolin; Tonofolin; Device: Point-of-care portable perfusion phantom (P4); 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.; Other Names: Phantom P4 calibration device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At time of surgery

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Harrison Kim, MBA, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Camptothecin; Alkaloids; Enzymes and Coenzymes; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Health Care Economics and Organizations; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Coenzymes; Albumins; Paclitaxel; Economics; Oxaliplatin; Irinotecan; Albumin-Bound Paclitaxel; Gemcitabine; Fluorouracil; Leucovorin; Specimen Handling; 130-nm albumin-bound paclitaxel; dehydroftorafur; Taxes
• Other Study ID Numbers: OSU-25209; R01CA290435 (U.S. NIH Grant/Contract); NCI-2026-04864 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No