DCE-MRI Guided Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Borderline-resectable Pancreatic Cancer

Treatments: Device: Point-of-care Portable Perfusion Phantom (P4)

Study type: Interventional

Funder types: Other

Identifiers

NCT06173310

300012110

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

borderline-resectable pancreatic cancer (BRPC)

Experimental group

Treatment:

Device: Point-of-care Portable Perfusion Phantom (P4)