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

NCT ID: NCT04588025

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-14
• Study Completion Date: 2026-10-31

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy Volunteers

Group Type: ACTIVE_COMPARATOR

Point-of-care Portable Perfusion Phantom, P4

Intervention Type: DEVICE

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.

Pancreatic Cancer Participants

Group Type: ACTIVE_COMPARATOR

Point-of-care Portable Perfusion Phantom, P4

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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 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:

• 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Harrison Kim

Associate Professor, Division of Advanced Medical Imaging Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harrison Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

April Riddle, BSRT

Role: CONTACT

ariddle@uabmc.edu

205-934-6504

Stephanie Ford, BS

Role: CONTACT

smford@uabmc.edu

205-934-4080

Facility Contacts

April Riddle, BSRT

Role: primary

ariddle@uabmc.edu

205-934-6504

Harrison Kim, PhD

Role: backup

Desiree Morgan, M.D.

Role: backup

Yufeng Li, PhD

Role: backup

Seth Smith, PhD

Role: primary

seth.smith@vumc.org

615-322-6211

Junzhong Xu, PhD

Role: backup

Other Identifiers

IRB- 300003007

Identifier Type: -

Identifier Source: org_study_id