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Borderline Resectable Pancreatic Ductal AdenocarcinomaPhase 1/2NCT07705919

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

A Phase 1/2 study testing Biospecimen Collection, Computed Tomography and Dynamic Contrast-Enhanced Magnetic Resonance Imaging in people with Borderline Resectable Pancreatic Ductal Adenocarcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 31 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Shafia Rahman, MD, shafia.rahman@osumc.edu

    Shafia Rahman, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Biospecimen Collection, Computed Tomography, Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Fluorouracil, Gadolinium-Chelate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT scan

  • Dynamic Contrast-Enhanced Magnetic Resonance ImagingProcedure or surgery

    Also called DCE, DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI

    Undergo DCE-MRI

  • FluorouracilDrug

    Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione

    Given fluorouracil

  • Gadolinium-ChelateDrug

    Also called Gadolinium Coordination Complex, Gadolinium-based Contrast Agent, Gadolinium-Chelant Complex

    Given IV

  • GemcitabineDrug

    Also called dFdC, dFdCyd, Difluorodeoxycytidine

    Given gemcitabine

  • IrinotecanDrug

    Given irinotecan

  • Leucovorin CalciumDrug

    Also called Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate

    Undergo leucovorin

  • Nab-paclitaxelDrug

    Also called ABI 007, ABI-007, ABI007, Abraxane

    Given nab-paclitaxel

  • OxaliplatinDrug

    Also called 1-OHP, Ai Heng, Aiheng, Dacotin

    Given oxaliplatin

  • Point-of-care portable perfusion phantom (P4)Device

    Also called Phantom P4 calibration device

    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.

Study groups in NCT07705919
Study groupRoleWhat they receive
Diagnostic (DCE-MRI)ExperimentalWithin 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.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Drug: Fluorouracil; Drug: Gadolinium-Chelate; Drug: Gemcitabine; Drug: Irinotecan; Drug: Leucovorin Calcium; Drug: Nab-paclitaxel; Drug: Oxaliplatin; Device: Point-of-care portable perfusion phantom (P4)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At time of surgery

Secondary outcomes (1)

  1. 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.

    Measured: At time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07705919
Sponsor's protocol ID
OSU-25209
Other IDs
R01CA290435, NCI-2026-04864
Status last verified
Sep 2026
First submitted
10 Jul 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Biospecimen Collection, Computed Tomography and Dynamic Contrast-Enhanced Magnetic Resonance Imaging in people with Borderline Resectable Pancreatic Ductal Adenocarcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 resection rate (time frame: At time of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07705919.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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