DCE-MRI Guided Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer

NCT ID: NCT06173310

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2029-03-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

borderline-resectable pancreatic cancer (BRPC)

Group Type: EXPERIMENTAL

Point-of-care Portable Perfusion Phantom (P4)

Intervention Type: 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.

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Harrison Kim

Professor, Division of Advanced Medical Imaging Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harrison Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Indiana University Medical Center

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sebastian Eady, BS

Role: CONTACT

smeady@uabmc.edu

205-996-2636

Facility Contacts

Sebastian Eady, BS

Role: primary

smeady@uabmc.edu

205-996-2636

D D

Role: primary

D@UAB.EDU

5555555555

Other Identifiers

300012110

Identifier Type: -

Identifier Source: org_study_id