Back to resultsDisposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response
Primary Purpose
Pancreatic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point-of-care Portable Perfusion Phantom, P4
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Cancer
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.
Sites / Locations
- University of Alabama at BirminghamRecruiting
- Vanderbilt University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Healthy Volunteers
Pancreatic Cancer Participants
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04588025
First Posted
October 7, 2020
Last Updated
October 19, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT04588025
Brief Title
Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response
Official Title
Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The healthy group is going to be the group to establish a baseline for the pancreatic group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Active Comparator
Arm Title
Pancreatic Cancer Participants
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Point-of-care Portable Perfusion Phantom, P4
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reproducibility of quantitative DCE-MRI measurement with MRI 1.
Description
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.
Time Frame
Baseline
Title
Reproducibility of quantitative DCE-MRI measurement with MRI 2.
Description
This outcome is assigned to the 5 healthy volunteers that we will be evaluated on 3 different MRIs.
Time Frame
Baseline to 3-days (MRI number 2)
Title
Reproducibility of quantitative DCE-MRI measurement with MRI 3.
Description
This outcome is assigned to the 5 healthy volunteers that we will be evaluated on 3 different MRIs.
Time Frame
Baseline to 7-days (MRI number 3)
Title
Measure change in blood flow within the pancreatic cancer as measured by the P4.
Description
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.
Time Frame
Baseline
Title
Measure change in blood flow within the pancreatic cancer as measured by the P4.
Description
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.
Time Frame
6 weeks post-therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
April Riddle, BSRT
Phone
205-934-6504
Email
ariddle@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Ford, BS
Phone
205-934-4080
Email
smford@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harrison Kim, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
April Riddle, BSRT
Phone
205-934-6504
Email
ariddle@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Harrison Kim, PhD
First Name & Middle Initial & Last Name & Degree
Desiree Morgan, M.D.
First Name & Middle Initial & Last Name & Degree
Yufeng Li, PhD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seth Smith, PhD
Phone
615-322-6211
Email
seth.smith@vumc.org
First Name & Middle Initial & Last Name & Degree
Junzhong Xu, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
To be determined
Learn more about this trial
Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response
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