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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Dynamic Contrast-Enhanced Magnetic Resonance Imaging
  • Fluorouracil
  • Gadolinium-Chelate
  • Gemcitabine
  • Irinotecan
  • Leucovorin Calcium
  • Nab-paclitaxel
  • Oxaliplatin
  • Point-of-care portable perfusion phantom (P4)

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Ohio State University Comprehensive Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator