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DWI/MRI for Detecting Colorectal and Appendiceal Cancer (DWI-HighRisk Trial)
N/A
Recruiting
Led By Alexandre Brind'Amour, MD
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
DWI-HighRisk Trial Summary
This trial aims to evaluate how well DWI/MRI detects PM in people with CRC or AN who have a high risk of recurrence. It will compare DWI/MRI to CT and laparoscopy to see which works best.
Who is the study for?
This trial is for patients with high-risk colorectal or appendiceal cancers without distant metastases, who are fit enough for potential surgery (ECOG 0 or 1), and have features indicating a risk of peritoneal recurrence. It's not for those unable to undergo MRI, unfit for surgery (ECOG 2+), with low-grade tumors, or unresected synchronous peritoneal metastases.Check my eligibility
What is being tested?
The study tests the effectiveness of whole-body diffusion-weighted magnetic resonance imaging (WB-DWI/MRI) in detecting peritoneal metastases during follow-up of high-risk colorectal and appendiceal cancer patients. It compares this method to CT scans and diagnostic laparoscopy.See study design
What are the potential side effects?
Since the intervention involves MRI scanning, there are generally no direct side effects like you would expect from drugs; however, some individuals may experience discomfort due to the enclosed space of the MRI machine.
DWI-HighRisk Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Early peritoneal recurrence
Peritoneal findings
Secondary outcome measures
Early distant recurrence
DWI-HighRisk Trial Design
1Treatment groups
Experimental Treatment
Group I: DWI-High RiskExperimental Treatment1 Intervention
Patients to undergo DWI-MRI (patients included in the study).
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Who is running the clinical trial?
Laval UniversityLead Sponsor
417 Previous Clinical Trials
172,242 Total Patients Enrolled
2 Trials studying Peritoneal Carcinomatosis
51 Patients Enrolled for Peritoneal Carcinomatosis
Ciusss de L'Est de l'Île de MontréalOTHER
70 Previous Clinical Trials
5,530 Total Patients Enrolled
2 Trials studying Peritoneal Carcinomatosis
36 Patients Enrolled for Peritoneal Carcinomatosis
Alexandre Brind'Amour, MDPrincipal InvestigatorLaval University
2 Previous Clinical Trials
51 Total Patients Enrolled
2 Trials studying Peritoneal Carcinomatosis
51 Patients Enrolled for Peritoneal Carcinomatosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has not spread to distant parts of my body.I have a low-grade tumor in my appendix.I have cancer spread to the lining of my abdomen that hasn't been surgically removed.I am not fit for major surgery due to my physical condition.My scans and surgery reports show no remaining cancer in my abdomen.My condition does not have a high risk of recurring in the abdomen lining.I am fit for surgery to remove as much cancer as possible (ECOG 0 or 1).My scans show cancer has spread to distant parts of my body.I have been diagnosed with colorectal cancer or a serious type of appendiceal cancer.I had surgery to remove cancer that spread to my abdomen or ovaries, or my cancer caused a hole in my intestine.
Research Study Groups:
This trial has the following groups:- Group 1: DWI-High Risk
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the participant pool for this research project?
"Affirmative. As per the details on clinicaltrials.gov, recruitment for this medical trial has been ongoing since September 1st 2022 and continues to date. Two sites are actively looking for 30 participants in total."
Answered by AI
Is the recruitment of participants still ongoing for this experiment?
"Affirmative. Clinicaltrials.gov states that this clinical trial is actively recruiting, having been launched on September 1st 2022 and last updated November 16th of the same year. The study seeks to recruit 30 individuals from two sites."
Answered by AI
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