Diagnostic Value of DWI-MRI for Detection of Peritoneal Metastases in High-risk Pancreatic Ductal Adenocarcinoma. (DWI-PDAC)

October 3, 2023 updated by: Alexandre Brind'Amour, Laval University

Diagnostic Value of Diffusion-weighted Magnetic Resonance Imaging for Detection of Peritoneal Metastases in High-risk Pancreatic Ductal Adenocarcinoma: a Pilot Study.

Diffusion-weighted magnetic resonance imaging (DWI/MRI) has been described in recent literature as a highly sensitive and specific modality for the detection of peritoneal metastases (PM). It has been demonstrated to be superior to computed tomography (CT) for patients with known peritoneal disease from colorectal and gynaecological malignancies. However, the literature is scarce on the role of DWI/MRI in patients with pancreatic ductal-adenocarcinoma (PDAC). The aim of this study is to prospectively assess the added value of whole-body DWI/MRI (WB-DWI/MRI) to CT for detection of PM in the preoperative staging of patients with high-risk PDAC and evaluate how it correlates with intraoperative findings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective study from a single center. Patients will be evaluated and operated on by one of five surgeons with a subspeciality in hepato-biliary and pancreatic surgery. After thorough assessment for resectability, patients with PDAC considered resectable based on CT, but at high-risk for peritoneal disease, will be prospectively included in the study and assessed with WB-DWI/MRI within 4 weeks of the planned surgery, with the standard protocol including the following sequences: Patients will drink 1L of pineapple juice one hour prior to the examination in order to provide a negative intraluminal contrast. Patients will receive 20 mg of intravenous hyoscine butylbromide at the beginning of the MR exam in order to reduce bowel peristalsis. Sequences will include Axial et Coronal T2WI of the abdomen and pelvis, axial DWI with b values of 0, 50 and 1000 of the abdomen and pelvis, as well as Pre and post gadolinium-based contrast Axial and Coronal 3D T1WGRE. Patients with no evidence of PM on WB-DWI/MRI will be operated on and undergo pancreatic resection following the usual exploration of the peritoneal cavity in case of occult metastatic disease. Patients with suspicion of PM on WB-DWI/MRI will be approached with a diagnostic laparoscopy first, then undergo pancreatic resection if no evidence of PM is found. Each case will be followed for at least 6 months.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1R 2J6
        • Recruiting
        • CHU de Quebec
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed diagnosis of pancreatic ductal adenocarcinoma.
  • Resectable disease or borderline resectable disease based on CT.
  • Tumor size ≥ 3 cm.
  • CA 19-9 ≥ 400 U/mL with normal bilirubin level (< 40)
  • No evidence of distant metastases.
  • Patient fit for pancreatic resection (ECOG 0 or 1).

Exclusion Criteria:

  • Impossibility to obtain tissue diagnosis preoperatively confirming pancreatic ductal adenocarcinoma.
  • Locally advanced disease on CT.
  • Tumor size < 3 cm.
  • CA 19-9 < 400 U/mL or CA 19-9 ≥ 400 U/mL with no preoperative drainage.
  • Suspicion of distant metastases, including peritoneal metastases, on CT.
  • Patient who is unable to have MRI.
  • Patient unfit for pancreatic resection (ECOG 2 or more).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DWI-MRI
Patients to undergo DWI-MRI (patients include in the study.
Diagnostic test: Whole-body diffusion-weighted magnetic resonance imaging
See arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peritoneal findings
Time Frame: 24 months
The number of cases in which peritoneal findings on MRI altered clinical management.
24 months
Unexpected abortion
Time Frame: 24 months
The rate of unexpected aborted surgery due to peritoneal metastases discovery at surgery.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early distant recurrence
Time Frame: 30 months
The number of cases with early distant recurrence (less than 6 months).
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Alexandre Brind'Amour, MD, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-6186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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