NCT04588025

Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to investigate whether the therapeutic response of pancreatic tumors can be accurately assessed using quantitative DCE-MRI, when the inter/intra-scanner variability is reduced using the Point-of-care Portable Perfusion Phantom, P4. The intra-scanner variability over time leads to errors in therapy monitoring, while the inter-scanner variability impedes the comparison of data among institutes. The P4 is small enough to be imaged concurrently in the bore of a standard MRI scanner with a patient for real-time quality assurance. The P4 is safe, inexpensive and easily operable, thus it has great potential for widespread and routine clinical use for accurate diagnosis, prognosis and therapy monitoring. This study has identified two arms, one arm is healthy individuals that will undergo DCE MRI at three different MRI locations to establish baseline results. The healthy volunteers will undergo these MRIs prior to the second arm, which contains patients with pancreatic cancer. The pancreatic cancer patients will only have DCE MRI done at one location.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DEVICE	Point-of-care Portable Perfusion Phantom, P4	P4 is a perfusion phantom developed by Dr. Harrison Kim that can significantly reduce variation in quantitating perfusion of human abdominal tissues across MRI scanners.

Timeline

• Start date: 2020-10-14
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2020-10-19
• Last updated: 2026-02-27

Locations

2 sites across 1 country: United States