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Diagnostic Value of Diffusion-weighted Magnetic Resonance in High-risk Colorectal and Appendiceal Neoplasms (DWI-HighRisk)

Primary Purpose

Peritoneal Carcinomatosis, Peritoneal Metastases, Appendix Cancer

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 Peritoneal Carcinomatosis focused on measuring DWI, CRC, Carcinomatosis, Diagnostic laparoscopy

Eligibility Criteria

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

Inclusion Criteria: 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). Exclusion Criteria: 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).

Sites / Locations

  • CIUSSS de l'Est-de-l'Île-de-MontréalRecruiting
  • CHU de QuébecRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DWI-High Risk

Arm Description

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

Outcomes

Primary Outcome Measures

Peritoneal findings
The number of cases in which peritoneal findings on MRI matched with surgical exploration.
Early peritoneal recurrence
The number of cases with early peritoneal recurrence after MRI.

Secondary Outcome Measures

Early distant recurrence
The number of cases with early distant recurrence.

Full Information

First Posted
November 10, 2022
Last Updated
November 16, 2022
Sponsor
Laval University
Collaborators
Ciusss de L'Est de l'Île de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT05623787
Brief Title
Diagnostic Value of Diffusion-weighted Magnetic Resonance in High-risk Colorectal and Appendiceal Neoplasms
Acronym
DWI-HighRisk
Official Title
Diagnostic Value of Diffusion-weighted Magnetic Resonance Imaging for Detection of Peritoneal Recurrence in Patients With High-risk Colorectal and Appendiceal Neoplasms : a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Ciusss de L'Est de l'Île de Montréal

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 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.
Detailed Description
This is a multicentric, prospective study (CHU de Québec and Hôpital Maisonneuve-Rosemont). Patients will be referred to one of six surgeons with a subspeciality in peritoneal surface oncology after their index surgery for CRC or AN. After thorough assessment, patients judged without residual peritoneal disease, but at high-risk for peritoneal recurrence, will be prospectively included in the study. Patients will be assessed with CT and WB-DWI/MRI twelve months after their index surgery. For WB-DWI/MRI, the standard protocol will include the following sequences: Patients will drink 1L of pineapple juice one hour prior to the examination in order to provide a negative intraluminal contrast. They 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. All patients included in the study will then undergo diagnostic laparoscopy, to provide correlation with imaging findings. Patients with no evidence of peritoneal recurrence on CT, WB-DWI/MRI and diagnostic laparoscopy will continue to be followed with serial CT and blood tumor markers (CEA, CA 19-9) as done on a routine basis. Patients with confirmed peritoneal disease at diagnostic laparoscopy will be further evaluated for cytoreductive surgery, with or without hyperthermic intraperitoneal chemotherapy. The study duration will be two years for all participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Carcinomatosis, Peritoneal Metastases, Appendix Cancer, Appendix Neoplasm, Colorectal Cancer
Keywords
DWI, CRC, 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
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DWI-High Risk
Arm Type
Experimental
Arm Description
Patients to undergo DWI-MRI (patients included 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 matched with surgical exploration.
Time Frame
24 months
Title
Early peritoneal recurrence
Description
The number of cases with early peritoneal recurrence after MRI.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Early distant recurrence
Description
The number of cases with early distant recurrence.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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).
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
CIUSSS de l'Est-de-l'Île-de-Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikaël L. Soucisse, MD
Phone
+14182523400
Ext
5766
First Name & Middle Initial & Last Name & Degree
Pierre Dubé, MD
First Name & Middle Initial & Last Name & Degree
Lucas Sidéris, MD
First Name & Middle Initial & Last Name & Degree
Jean-François Tremblay, MD
First Name & Middle Initial & Last Name & Degree
Julie Lafrance, MD
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
First Name & Middle Initial & Last Name & Degree
Cindy Boulanger-Gobeil, MD
First Name & Middle Initial & Last Name & Degree
Patricia Noël, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Diagnostic Value of Diffusion-weighted Magnetic Resonance in High-risk Colorectal and Appendiceal Neoplasms

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