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Prospective Evaluation of MRI Biomarkers in Pancreatic Ductal Adenocarcinoma

NCT02775786 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-09-19

No results posted yet for this study

Summary

This is a prospective cohort study in participants with pancreatic adenocarcinoma who are undergoing surgical resection. Participants will have up to two magnetic resonance imaging (MRI) scans with and without intravenous contrast. The MRI will be performed using either an extracellular contrast agent or using a macromolecular contrast agent. These contrast agents are routinely used in body MRI and are on formulary at this institution. Parameters will be compared to histopathology measures of mean vascular density and grade of fibrosis, respectively. The purpose is to establish a standard protocol for future clinical trials of treatments that would use MRI parameters as quantitative markers of treatment effect.

Conditions

  • Pancreatic Adenocarcinoma

Interventions

OTHER

MRIs with and without intravenous contrast (up to 2)

Participants will undergo up to two MRIs with and without intravenous contrast. The first MRI will be performed using an extracellular contrast agent and the second 1-14 days later, with a macromolecular contrast agent. If patient cannot undergo the second MRI for any reason eg. not enough time before surgery, one MRI with either contrast agent will still be used for analysis.

Sponsors & Collaborators

Principal Investigators

  • Lyndon Luk, MD · CUIMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2021-02-28
Completion
2021-02-10

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02775786 on ClinicalTrials.gov