Prospective Evaluation of MRI Biomarkers in Pancreatic Ductal Adenocarcinoma

NCT02775786 | Completed

• 1 other identifier: AAAL2505
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pancreatic Adenocarcinoma; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

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

  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.

  Two years

Study Arms (2)

Healthy Volunteers

NO INTERVENTION

Normal volunteers with no pancreas mass or risk factors for pancreas cancer will be recruited for MRI protocol optimization and nothing more. No intravenous contrast will be given. They will be asked to lie in the scanner for up to 1 hour and non-contrast imaging will be performed.

Pancreatic Mass or Risk Factors Group

EXPERIMENTAL

Participants with pancreatic adenocarcinoma who are planning to undergo surgical resection. 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 .

Other: MRIs with and without intravenous contrast (up to 2)

Interventions

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.

Pancreatic Mass or Risk Factors Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• Contraindication to MR imaging
• Pregnancy

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Lyndon Luk, MD

  CUIMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: May 18, 2016
• Study Start: November 1, 2013
• Primary Completion: February 1, 2021
• Study Completion: February 10, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)