DCE-MRI Guided Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer
1 other identifier
interventional
50
1 country
2
Brief Summary
The goal of this study is to test whether chemotherapy guided by a new imaging method named DCE-MRI can more effectively reduce a pancreatic tumor, enabling curable surgery, over the conventional method when a tumor is categorized as borderline resectable pancreatic cancer. UAB radiological research team has been studying a cutting-edge imaging technique named dynamic contrast-enhanced magnetic resonance imaging, or DCE-MRI, for over 10 years. This technique has been globally used to calculate the blood flow of various tissues, including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a pancreatic tumor typically has low blood flow, so it can be used as an indicator to identify the presence of a pancreatic tumor. In addition, an effective therapy can result in the increase of blood flow in a pancreatic tumor during the early period of treatment. Therefore, the investigators may be able to determine whether the undergoing therapy is effective or not by measuring the change of blood flow in the pancreatic tumor and deciding whether to continue the therapy or try a different one.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2023
CompletedFirst Posted
Study publicly available on registry
December 15, 2023
CompletedStudy Start
First participant enrolled
October 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
February 27, 2026
February 1, 2025
4.4 years
December 7, 2023
February 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To measure the reproducibility of qDCE-MRI measurement of BRPC.
The pharmacokinetic (PK) parameter within the region of interest (ROI) will be averaged at each scan after P4-based error correction, and the mean values of two scans will be compared to calculate the reproducibility coefficient (%RDC) using the equation, %RDC=2.77wCV, where wCV is the within-subject coefficient of variation. The %RDC before P4-based error correction will also be calculated for comparison. Data reproducibility will be assessed using the intra-class correlation coefficient (ICC) as well. ICC = σ 2b / (σ 2b+ σ 2w), where σb is between-subject standard deviation and σw is within-subject standard deviation.
6 weeks +/- 2 weeks
Study Arms (1)
borderline-resectable pancreatic cancer (BRPC)
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Adult patients (age 19 years or older).
- Patients with newly diagnosed and untreated borderline resectable pancreatic cancer.
- Patients with signed informed consent.
You may not qualify if:
- Any history of prior radiation or chemotherapy or surgical removal for pancreatic cancer.
- Participants with safety contraindications to MRI examination (determined by standard clinical screening).
- Participants who are pregnant, lactating or are planning to become pregnant during the study.
- Participants who are planning to father a child during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Harrison Kim, PhD
Ohio State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 7, 2023
First Posted
December 15, 2023
Study Start
October 10, 2024
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
February 27, 2026
Record last verified: 2025-02