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2024-10-10
2029-03
2029-03
50
NCT06173310
University of Alabama at Birmingham
University of Alabama at Birmingham
INTERVENTIONAL
DCE-MRI Guided Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-12-07 | N/A | 2025-02-13 |
2023-12-07 | N/A | 2025-02-17 |
2023-12-15 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: borderline-resectable pancreatic cancer (BRPC) | DEVICE: Point-of-care Portable Perfusion Phantom (P4)
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Sebastian Eady, BS Phone Number: 205-996-2636 Email: smeady@uabmc.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
