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NCT Number: NCT02775786

Prospective Evaluation of MRI Biomarkers in Pancreatic Ductal Adenocarcinoma

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.

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Key information

Conditions

Pancreatic Adenocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

This is a prospective cohort study of dynamic contrast enhanced MRI (DCE-MRI), which includes diffusion weighted imaging (DWI-MRI) in participants with pancreatic adenocarcinoma who are undergoing surgical resection. Participants will have up to two 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. Quantitative parameters of volume transfer coefficient (Ktrans) and apparent diffusion coefficient (ADC) will be calculated from the MRI sequences and each parameter will be compared to histopathology measures of mean vascular density and grade of fibrosis, respectively. The influence of the contrast agent (extracellular and macromolecular) on agreement between imaging parameters and histopathology will be assessed and agreement in Ktrans as derived from a one compartment and a two-compartment model will be assessed. If a participant is unable to receive intravenous contrast due to renal dysfunction or refuses IV contrast, the non-contrast portion of the exam will be used for analysis. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years of age.
  • Biopsy proved pancreatic ductal adenocarcinoma (PDA) and/or a pancreatic mass with imaging features suggestive of pancreatic adenocarcinoma planned for surgical resection.
  • No contraindication to MRI such as severe claustrophobia (not alleviated by oral anti-anxiolytics) or metal/mechanical devices in their body not considered magnetic resonance (MR) compatible at 1.5 Tesla (departmental MRI safety screening form)
  • No known allergy to gadolinium based contrast agent
  • For contrast enhanced studies, participant has an estimated glomerular filtration rate (GFR) >30 mg/dL using the modification of diet in Renal Disease (MDRD) formula. If the participant has an estimated GFR ≤30 mg/dL, they can still participate but no intravenous contrast will be administered.

Exclusion criteria

  • Contraindication to MR imaging
  • Pregnancy

Treatment and study plan

MRIs with and without intravenous contrast (up to 2)

Other

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.

Primary outcomes

  1. Correlation between Apparent Diffusion Coefficient (ADC) of pancreatic cancer based on MRI with percent fibrosis at histopathology

    Time frame: One year

Secondary outcomes

  1. Correlation between Ktrans of pancreatic cancer derived from dynamic contrast enhanced MRI performed with gadopentetate dimeglumine and mean vascular density quantified at histopathology.

    Time frame: Two years

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Assessing the Utility of Macromolecular Dynamic Contrast Enhanced MRI and Diffusion Weighted Imaging as Biomarkers for Vascular Permeability and Fibrosis in Pancreatic Cancer

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
May 18, 2016
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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