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

• ClinicalTrials.gov Identifier: NCT04588025
• Recruitment Status: Recruiting
• First Posted: October 19, 2020
• Last Update Posted: November 23, 2021
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Harrison Kim, University of Alabama at Birmingham

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pancreatic Cancer	Device: Point-of-care Portable Perfusion Phantom, P4	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 55 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The healthy group is going to be the group to establish a baseline for the pancreatic group.
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response
• Actual Study Start Date: October 14, 2020
• Estimated Primary Completion Date: October 2022
• Estimated Study Completion Date: October 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Healthy Volunteers	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.
Active Comparator: Pancreatic Cancer Participants	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.

Outcome Measures

Primary Outcome Measures :

1. Reproducibility of quantitative DCE-MRI measurement with MRI 1. [ Time Frame: Baseline ]
   This outcome is assigned to the 5 healthy volunteers that we will be evaluated on 3 different MRIs. Two scans will be done to establish baseline measures.
2. Reproducibility of quantitative DCE-MRI measurement with MRI 2. [ Time Frame: Baseline to 3-days (MRI number 2) ]
   This outcome is assigned to the 5 healthy volunteers that we will be evaluated on 3 different MRIs.
3. Reproducibility of quantitative DCE-MRI measurement with MRI 3. [ Time Frame: Baseline to 7-days (MRI number 3) ]
   This outcome is assigned to the 5 healthy volunteers that we will be evaluated on 3 different MRIs.
4. Measure change in blood flow within the pancreatic cancer as measured by the P4. [ Time Frame: Baseline ]
   This is being done before therapy has been initiated and is being measured by the P4 during an MRI scan. The results will help determine if undergoing therapy is effective by measuring the change in blood flow and help to decide if we need to continue the current therapy or change to a different one. Blood flow often serves as a critical indicator showing a disease status.
5. Measure change in blood flow within the pancreatic cancer as measured by the P4. [ Time Frame: 6 weeks post-therapy ]
   This is being done after therapy has been initiated and is being measured by the P4 during an MRI scan. The results will help determine if undergoing therapy is effective by measuring the change in blood flow and help to decide if we need to continue the current therapy or change to a different one. Blood flow often serves as a critical indicator showing a disease status.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: April Riddle, BSRT; 205-934-6504; ariddle@uabmc.edu

Contact: Stephanie Ford, BS; 205-934-4080; smford@uabmc.edu

Locations

United States, Alabama

University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35294

Contact: April Riddle, BSRT 205-934-6504 ariddle@uabmc.edu

Principal Investigator: Harrison Kim, PhD

Sub-Investigator: Desiree Morgan, M.D.

Sub-Investigator: Yufeng Li, PhD

United States, Tennessee

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37232

Contact: Seth Smith, PhD 615-322-6211 seth.smith@vumc.org

Principal Investigator: Junzhong Xu, PhD

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

• Principal Investigator: Harrison Kim, PhD; University of Alabama at Birmingham

More Information

• Responsible Party: Harrison Kim, Associate Professor, Division of Advanced Medical Imaging Research, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT04588025
• Other Study ID Numbers: IRB- 300003007
• First Posted: October 19, 2020
• Last Update Posted: November 23, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: To be determined

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases