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Recruiting NCT06173310

DCE-MRI Guided Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer

No phase Interventional Borderline-resectable Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Point-of-care Portable Perfusion Phantom (P4).
Who it may be relevant to
Registry conditions: Borderline-resectable Pancreatic Cancer. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device 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 measures

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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 2 centers
  • Indiana University Medical Center — Indianapolis
  • The Ohio State University — Columbus

Identifiers

NCT: NCT06173310 · 300012110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗