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

Primary Purpose

Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreas Adenocarcinoma, Peritoneal Metastases

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Whole-body diffusion-weighted magnetic resonance imaging
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreas Cancer, Duct Cell Adenocarcinoma focused on measuring DWI, PDAC, Carcinomatosis, Diagnostic laparoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CHU de QuébecRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DWI-MRI

Arm Description

Patients to undergo DWI-MRI (patients include in the study.

Outcomes

Primary Outcome Measures

Peritoneal findings
The number of cases in which peritoneal findings on MRI altered clinical management.
Unexpected abortion
The rate of unexpected aborted surgery due to peritoneal metastases discovery at surgery.

Secondary Outcome Measures

Early distant recurrence
The number of cases with early distant recurrence (less than 6 months).

Full Information

First Posted
April 11, 2022
Last Updated
October 3, 2023
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT05340569
Brief Title
Diagnostic Value of DWI-MRI for Detection of Peritoneal Metastases in High-risk Pancreatic Ductal Adenocarcinoma.
Acronym
DWI-PDAC
Official Title
Diagnostic Value of Diffusion-weighted Magnetic Resonance Imaging for Detection of Peritoneal Metastases in High-risk Pancreatic Ductal Adenocarcinoma: a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreas Adenocarcinoma, Peritoneal Metastases, Peritoneal Carcinomatosis
Keywords
DWI, PDAC, Carcinomatosis, Diagnostic laparoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DWI-MRI
Arm Type
Experimental
Arm Description
Patients to undergo DWI-MRI (patients include in the study.
Intervention Type
Diagnostic Test
Intervention Name(s)
Whole-body diffusion-weighted magnetic resonance imaging
Intervention Description
See arm description.
Primary Outcome Measure Information:
Title
Peritoneal findings
Description
The number of cases in which peritoneal findings on MRI altered clinical management.
Time Frame
24 months
Title
Unexpected abortion
Description
The rate of unexpected aborted surgery due to peritoneal metastases discovery at surgery.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Early distant recurrence
Description
The number of cases with early distant recurrence (less than 6 months).
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Brind'Amour, MD
Phone
+14185254444
Ext
15925
Email
godonco@chudequebec.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Brind'Amour, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Québec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Brind'Amour
Phone
+14185254444
Ext
15925
Email
godonco@chudequebec.ca

12. IPD Sharing Statement

Plan to Share IPD
No
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Diagnostic Value of DWI-MRI for Detection of Peritoneal Metastases in High-risk Pancreatic Ductal Adenocarcinoma.

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