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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588025
• Other study ID #: IRB- 300003007
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: April Riddle, BSRT
• Phone: 205-934-6504
• Email: ariddle[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility of quantitative DCE-MRI measurement with MRI 1.	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.	Baseline
Primary	Reproducibility of quantitative DCE-MRI measurement with MRI 2.	This outcome is assigned to the 5 healthy volunteers that we will be evaluated on 3 different MRIs.	Baseline to 3-days (MRI number 2)
Primary	Reproducibility of quantitative DCE-MRI measurement with MRI 3.	This outcome is assigned to the 5 healthy volunteers that we will be evaluated on 3 different MRIs.	Baseline to 7-days (MRI number 3)
Primary	Measure change in blood flow within the pancreatic cancer as measured by the P4.	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.	Baseline
Primary	Measure change in blood flow within the pancreatic cancer as measured by the P4.	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.	6 weeks post-therapy