Borderline-resectable Pancreatic CancerNCT06173310
DCE-MRI Guided Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer
A study testing Point-of-care Portable Perfusion Phantom (P4) in people with Borderline-resectable Pancreatic Cancer, run by Ohio State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Borderline-resectable Pancreatic Cancer
- What is being tested?
- Point-of-care Portable Perfusion Phantom (P4)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2024to Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age 19 years or older).
- Patients with newly diagnosed and untreated borderline resectable pancreatic cancer.
- Patients with signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Tamara Stein, MPH, 614-293-8315, Tamara.Steinm@osumc.edu
Harrison Kim, PhD
- Recruiting
Indiana University Medical Center
Indianapolis, Indiana, 46202
D D, 5555555555, D@UAB.EDU
Asiq Masood, MD
About this study
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.
- Conditions
- Borderline-resectable Pancreatic Cancer
- Being tested
- Point-of-care Portable Perfusion Phantom (P4)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care Portable Perfusion Phantom (P4)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.
| Study group | Role | What they receive |
|---|---|---|
| borderline-resectable pancreatic cancer (BRPC) | Experimental | Not described Receives: Device: Point-of-care Portable Perfusion Phantom (P4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks +/- 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start10 Oct 2024
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline-resectable Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harrison Kim, Ohio State University
- Investigators
- Harrison Kim, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173310
- Sponsor's protocol ID
- STUDY20260044
- Status last verified
- Oct 2026
- First submitted
- 7 Dec 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No