Penn Quantitative Imaging Resource for Pancreatic Cancer

News

Phase-2 Clinical Trial Testing Utility of MRI Markers Gained IRB Approval

August 22, 2019

University of Pennsylvania Institutional Review Board (IRB) has approved our “Phase II Study Of Stromal Changes Detected By DCE- and DW-MRI In Response To PEGPH20 Combined With Chemotherapy In Subjects With Locally-Advanced Pancreatic Cancer”. Dr. Peter O’Dwyer, MD, and Dr. Thomas Karasic, MD, are leading this trial serving as the Sponsor Investigator and the Principal Investigator, respectively. A team of medical oncologists participate in this trial including Mark O’Hara, MD; Kim Reiss-Binder, MD; Ursina Teitelbaum, MD; Charles Schneider, MD; Jennifer Eads, MD.

This trial focuses on testing the utility of quantitative MR imaging markers, including dynamic contrast enhanced (DCE)-MRI, for detection of pancreatic tumor responses to stroma-directed drug, PEGPH20, a hyaluronidase. Preclinical MRI studies in mouse models of PDA (pancreatic ductal adenocarcinoma) has shown the high sensitivity of quantitative DCE-MRI to PEGPH20 treatment (Clinical Cancer Research, 2019 Apr 1; 25(7):2314-2322).

The U24 team members who also participate in this clinical trial include Drs. Mark Rosen, Hee Kwon Song and Rong Zhou.

Center for Magnetic Resonance Imaging & Spectroscopy (CAMRIS) has approved the MRI protocols on this trial.

IRB Protocol Approved by Halozyme

January 18, 2019

Halozyme Therapeutics approved the phase-2 clinical trial our team has proposed, and the company is working with us to finalize the details of the sponsorship.  This phase-2 trial is entitled "Phase II Study Of Stromal Changes Detected By DCE- and DW-MRI In Response To PEGPH20 Combined With Chemotherapy In Subjects With Locally-Advanced Pancreatic Cancer". The primary goal of this trial is to test the utility of DCE-MRI and DWI markers for assessing the PDA stroma, the early response to stroma-directed investigational drug, PEGPH20, which is developed by Halozyme and is currently under phase-3 clinical trial.

Clinical Cancer Research manuscript accepted

December 4, 2018  

Manuscript titled “Dynamic contrast-enhanced MRI detects responses to stroma-directed therapy in mouse models of pancreatic ductal adenocarcinoma” was accepted by CCR. This is the first paper supported by the U24CA231858. Congratulations!

IRB Protocol Concept Presented

October 12, 2018

At PCRC SWAT Team Quarterly Meeting, Dr. Thomas Karasic presented the concept of a phase-2 clinical trial titled “Phase II Study Of Stromal Changes Detected By DCE- and DW-MRI In Response To PEGPH20 Combined With Chemotherapy In Subjects With Locally-Advanced Pancreatic Cancer”. PCRC - Pancreatic Cancer Research Center- is a research institute of Abramson Cancer Center of University of Pennsylvania Health System.