Recruiting

DCE-MRI Guided Chemotherapy

Sponsor:

Ohio State University

Code:

NCT06173310

Conditions

Borderline-resectable Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Point-of-care Portable Perfusion Phantom (P4)

Study Details

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.

Conditions

Borderline-resectable Pancreatic Cancer

Study ID

NCT06173310

Start date

Oct 10, 2024

Status verified date

Feb, 2025

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients (age 19 years or older).
  • Patients with newly diagnosed and untreated borderline resectable pancreatic cancer.
  • Patients with signed informed consent.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: borderline-resectable pancreatic cancer (BRPC)

Interventions

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.

Primary outcome measure

  • To measure the reproducibility of qDCE-MRI measurement of BRPC. [ Time Frame: 6 weeks +/- 2 weeks ]

Central Contacts and Locations

Central contacts

Locations

Indiana University Medical Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Asiq Masood, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Harrison Kim, PhD

More Information

Sponsor

Ohio State University

Last update posted

Feb 27, 2026

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-02-27.