Diagnostic Value of Diffusion-weighted Magnetic Resonance in High-risk Colorectal and Appendiceal Neoplasms

NCT05623787 | Active Not Recruiting

• 1 other identifier: MP-20-2022-6366
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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 CT for patients with known peritoneal disease from colorectal and gynaecological malignancies as a staging tool for cytoreductive surgery. It was also demonstrated to be superior for the detection of PM for gastric cancer patients otherwise considered with a resectable tumor. However, the literature is scarce on the role of DWI/MRI in the detection of peritoneal recurrence for patients with high-risk features, either colorectal cancer (CRC) or appendiceal neoplasms (AN). The aim of this study is to prospectively assess the added value of whole-body DWI/MRI (WB-DWI/MRI) to CT and diagnostic laparoscopy for detection of PM in the follow-up of patients presenting with CRC or AN and high-risk features for peritoneal recurrence and evaluate how it correlates with intraoperative findings.

Conditions

Peritoneal Carcinomatosis; Peritoneal Metastases; Appendix Cancer; Appendix Neoplasm; Colorectal Cancer

Keywords

DWI; CRC; Carcinomatosis; Diagnostic laparoscopy

Outcome Measures

Primary Outcomes (2)

• Peritoneal findings

  The number of cases in which peritoneal findings on MRI matched with surgical exploration.

  24 months

• Early peritoneal recurrence

  The number of cases with early peritoneal recurrence after MRI.

  36 months

Secondary Outcomes (1)

• Early distant recurrence

  36 months

Study Arms (1)

DWI-High Risk

EXPERIMENTAL

Patients to undergo DWI-MRI (patients included 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-High Risk

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 colorectal cancer or high-risk appendiceal neoplasm (High grade Appendiceal Mucinous Neoplasm (HAMN), goblet-cell carcinoma or adenocarcinoma).
• No evidence of residual peritoneal disease based on referring surgeon operating report and preoperative imaging.
• At least one high-risk feature for peritoneal recurrence, including:
• Synchronous peritoneal metastases resected at index surgery;
• Synchronous ovarian metastases resected at index surgery;
• Perforated primary tumor.
• No evidence of distant metastases.
• Patient fit for cytoreductive surgery, if required (ECOG 0 or 1).

You may not qualify if:

• Unresected synchronous peritoneal metastases at referral.
• Low grade Appendiceal Mucinous Neoplasm (LAMN).
• No high-risk feature for peritoneal recurrence.
• Evidence of distant metastases on preoperative imaging.
• Patient who is unable to have MRI.
• Patient unfit for cytoreductive surgery, if required (ECOG 2 or more).

Sponsors & Collaborators

• Laval University: lead
• Ciusss de L'Est de l'Île de Montréal: collaborator

Study Sites (2)

CIUSSS de l'Est-de-l'Île-de-Montréal

Montreal, Quebec, H1T 2M4, Canada

Location

CHU de Québec

Québec, Quebec, G1R 2J6, Canada

Location

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MeSH Terms

Conditions

Peritoneal Neoplasms; Appendiceal Neoplasms; Colorectal Neoplasms; Carcinoma

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Cecal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Cecal Diseases; Intestinal Diseases; Colonic Diseases; Rectal 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: November 10, 2022
• First Posted: November 21, 2022
• Study Start: September 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 1, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)