Using a new device to improve MRI measurements for pancreatic cancer treatment response

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

This study is testing a new device to see if it can help doctors get more accurate MRI results when checking how well treatments are working for people with pancreatic cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Locations: 2 sites (Columbus, Ohio and 1 other locations)
• Trial ID: NCT04588025 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a Point-of-care Portable Perfusion Phantom (P4) in reducing variability in Dynamic Contrast Enhanced MRI (DCE-MRI) measurements for assessing pancreatic cancer therapy response. By using the P4 during MRI scans, the study seeks to enhance the accuracy of therapy monitoring and facilitate better comparisons of data across different medical institutions. The study includes healthy volunteers to establish baseline DCE-MRI results before assessing patients with pancreatic cancer. The P4 is designed to be safe, cost-effective, and easy to use, potentially allowing for routine clinical application.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 19 and older with pancreatic cancer who are undergoing treatment.

Not a fit: Patients with major health problems or contraindications to MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate monitoring of pancreatic cancer treatment responses, improving patient outcomes.

How similar studies have performed: While the use of phantoms in MRI is established, this specific application for pancreatic cancer therapy response measurement is novel and has not been extensively tested.

Eligibility criteria

Healthy Volunteer - a small number of healthy volunteers (5) will be used as the control group.

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participants having any known major health problems will be excluded.
* Participants with safety contraindications to MRI examination (determined by standard clinical screening).
* Participants on hemodialysis or with acute renal failure will be excluded. (Participants on hemodialysis and those with renal failure who receive intravenous gadolinium may be at increased risk for a condition called Nephrogenic systemic fibrosis/ Nephrogenic fibrosing dystrophy and thus will be excluded.)
* Participants may not be pregnant or lactating.
* Participants may not father a child while on this study as the treatment may indirectly affect an unborn child.
* Unless participants cannot have children because of surgery or other medical reasons, participants must have been using an effective form of birth control before starting the study.
* Participants must also agree to continue to use an effective form of birth control for 6 months after taking the study. Effective birth control includes birth control pills, patch, IUD (intrauterine device), condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause pregnancy.

Pancreatic Cancer Participants:

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Participants with safety contraindications to MRI examination (determined by standard clinical screening).
* Participants on hemodialysis or with acute renal failure will be excluded.
* Participants on hemodialysis and those with renal failure who receive intravenous gadolinium may be at increased risk for a condition called Nephrogenic systemic fibrosis/ Nephrogenic fibrosing dystrophy and thus will be excluded.
* Participants may not be pregnant or lactating.
* Participants may not father a child while on this study as the treatment may indirectly affect an unborn child.
* Unless participants cannot have children because of surgery or other medical reasons, participants must have been using an effective form of birth control before starting the study.
* Participants must also agree to continue to use an effective form of birth control for 6 months after taking the study. Effective birth control includes birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause pregnancy.

Where this trial is running

Columbus, Ohio and 1 other locations

• The Ohio State University — Columbus, Ohio, United States (Recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Harrison Kim, PhD — Ohio State University
• Study coordinator: Harrison Kim, PhD

Conditions Pancreatic Cancer