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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT07705919
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Borderline Resectable Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Dynamic Contrast-Enhanced Magnetic Resonance Imaging — PROCEDURE
    Undergo DCE-MRI
  • Fluorouracil — DRUG
    Given fluorouracil
  • Gadolinium-Chelate — DRUG
    Given IV
  • Gemcitabine — DRUG
    Given gemcitabine
  • Irinotecan — DRUG
    Given irinotecan
  • Leucovorin Calcium — DRUG
    Undergo leucovorin
  • Nab-paclitaxel — DRUG
    Given nab-paclitaxel
  • Oxaliplatin — DRUG
    Given oxaliplatin
  • Point-of-care portable perfusion phantom (P4) — 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 Details

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.

Key Dates

First listed
Jul 15, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Harrison Kim, MBA, PhD
[email protected]
614-814-1590
Harrison Kim, MBA, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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