Recruiting

Phase 1

Phase 2

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

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07705919

Conditions

Borderline Resectable Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Fluorouracil

Gadolinium-Chelate

Study Details

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.

Conditions

Borderline Resectable Pancreatic Ductal Adenocarcinoma

Study ID

NCT07705919

Start date

Oct 1, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen Collection

Undergo blood sample collection

Computed Tomography

Undergo CT scan

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Undergo DCE-MRI

Fluorouracil

Given fluorouracil

Gadolinium-Chelate

Given IV

Gemcitabine

Given gemcitabine

Irinotecan

Given irinotecan

Leucovorin Calcium

Undergo leucovorin

Nab-paclitaxel

Given nab-paclitaxel

Oxaliplatin

Given oxaliplatin

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.

Primary outcome measure

R0 resection rate [ Time Frame: At time of surgery ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066 OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Shafia Rahman, MD

shafia.rahman@osumc.edu

Principal Investigator:

Shafia Rahman, MD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.