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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
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• Targeted/planned enrollment in the study will include all racial/ethnic groups with no groups excluded on the basis of race, ethnicity or gender.

• Participants should be 19 years of age or older

• Participants should not have any known major health problems including but not limited to cancers, heart diseases, diabetes, high blood pressure and/or cholesterol, stroke, respiratory problems, and arthritis.

• Patients having biopsy proven locally advanced pancreatic cancer will be asked to participate in this study.

• Targeted/planned enrollment in the study will include all racial/ethnic groups, with no groups excluded on the basis of race, ethnicity or gender.

• Participants should be 19 years of age or older.

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
April Riddle, BSRT
ariddle@uabmc.edu
205-934-6504
Backup
Stephanie Ford, BS
smford@uabmc.edu
205-934-4080
Time Frame
Start Date: 2020-10-14
Estimated Completion Date: 2026-10
Participants
Target number of participants: 55
Treatments
Active_comparator: Healthy Volunteers
Active_comparator: Pancreatic Cancer Participants
Authors
Yufeng Li, Desiree Morgan
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov