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

NCT05340569 | Completed

• 1 other identifier: 2022-6186
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

DWI; PDAC; Carcinomatosis; Diagnostic laparoscopy

Outcome Measures

Primary Outcomes (2)

• Peritoneal findings

  The number of cases in which peritoneal findings on MRI altered clinical management.

  24 months

• Unexpected abortion

  The rate of unexpected aborted surgery due to peritoneal metastases discovery at surgery.

  24 months

Secondary Outcomes (1)

• Early distant recurrence

  30 months

Study Arms (1)

DWI-MRI

EXPERIMENTAL

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

Diagnostic Test: Whole-body diffusion-weighted magnetic resonance imaging

Interventions

Whole-body diffusion-weighted magnetic resonance imaging DIAGNOSTIC_TEST

See arm description.

DWI-MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

CHU de Québec

Québec, Quebec, G1R 2J6, Canada

Location

Related Publications (19)

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MeSH Terms

Conditions

Pancreatic Neoplasms; Peritoneal Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Abdominal Neoplasms; Peritoneal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Alexandre Brind'Amour, MD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 22, 2022
• Study Start: March 28, 2022
• Primary Completion: March 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)