DWI/MRI for Detecting Colorectal and Appendiceal Cancer

(DWI-HighRisk Trial)

Recruiting at 1 trial location

Overseen By Alexandre Brind'Amour, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Unresected metastases, LAMN, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

30 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What data supports the effectiveness of the treatment Whole-body diffusion-weighted magnetic resonance imaging for detecting colorectal and appendiceal cancer?

Research shows that diffusion-weighted imaging (DWI) combined with other MRI techniques is effective in diagnosing rectal cancer and assessing treatment response, suggesting it could be useful for detecting colorectal and appendiceal cancer as well. ^{1 2 3 4 5}

Is diffusion-weighted MRI (DWI/MRI) safe for humans?

The research articles do not specifically address safety concerns, but diffusion-weighted MRI (DWI/MRI) is generally considered safe as it is a non-invasive imaging technique that does not use ionizing radiation. ^{1 5 6 7 8}

How is DWI/MRI different from other treatments for colorectal and appendiceal cancer?

DWI/MRI is unique because it uses advanced imaging techniques to detect cancer, focusing on how water molecules move in tissues, which can help identify cancerous areas more accurately than traditional imaging methods. This approach is non-invasive and does not involve medication, making it different from standard treatments like chemotherapy or surgery. ^{1 3 9 10 11}

What is the purpose of this trial?

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.

Research Team

Alexandre Brind'Amour, MD

Principal Investigator

Laval University

Eligibility Criteria

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.

Inclusion Criteria

My cancer has not spread to distant parts of my body.

My scans and surgery reports show no remaining cancer in my abdomen.

I am fit for surgery to remove as much cancer as possible (ECOG 0 or 1).

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo CT and WB-DWI/MRI twelve months after their index surgery to assess for peritoneal recurrence.

12 months

1 visit (in-person)

Diagnostic Laparoscopy

Participants undergo diagnostic laparoscopy to correlate imaging findings with surgical exploration.

1-2 weeks

1 visit (in-person)

Follow-up

Participants with no evidence of peritoneal recurrence continue to be followed with serial CT and blood tumor markers.

24 months

Treatment Details

Interventions

• Whole-body diffusion-weighted magnetic resonance imaging

Trial Overview 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.

Participant Groups

Group I: DWI-High Risk Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Ciusss de L'Est de l'Île de Montréal

Collaborator

Trials

81

Recruited

6,400+

Findings from Research

In a study of 169 oncology patients, single breathhold diffusion-weighted imaging (DWI) during abdominal MRI revealed additional tumors in 77 patients (46%) for one observer and 67 patients (40%) for another, highlighting its effectiveness in detecting malignancies not seen in conventional imaging.

DWI not only identified tumors in patients with normal conventional MR exams but also clarified benign findings, demonstrating its added clinical value in oncology diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffusion-weighted MRI (DWI) in the oncology patient: value of breathhold DWI compared to unenhanced and gadolinium-enhanced MRI. Low, RN., Gurney, J.[2019]

In a study of 35 rectal cancer patients, diffusion-weighted imaging with background suppression (DWIBS) at 3.0 T MRI effectively differentiated between metastatic and non-metastatic lymph nodes, with significant differences in apparent diffusion coefficient (ADC) values and lymph node diameters.

The optimal cutoff values for ADC and lymph node diameters were established, indicating that while ADC values showed high sensitivity (93.8%), they had lower specificity (30.2%), suggesting that a combination of ADC measurements and size assessments is necessary for accurate diagnosis of lymph node metastasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnosis value of 3.0 T diffusion-weighted imaging with background suppression magnetic resonance for metastatic lymph nodes in rectal cancer]. Zhuang, XZ., Yu, SP., Cui, J., et al.[2011]

References

1. China pubmed.ncbi.nlm.nih.gov

[Diffusion weighted imaging combined with magnetic resonance conventional sequences for the diagnosis of rectal cancer]. [2009]

2. Germany pubmed.ncbi.nlm.nih.gov

Detection of distant metastases in rectal cancer: contrast-enhanced CT vs whole body MRI. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Simple measurements on diffusion-weighted MR imaging for assessment of complete response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer. [2022]

4. Poland pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in locally advanced rectal cancer: quantitative evaluation of the complete response to neoadjuvant therapy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of diffusion-weighted magnetic resonance imaging in identification of colorectal cancer. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Diffusion-weighted MRI (DWI) in the oncology patient: value of breathhold DWI compared to unenhanced and gadolinium-enhanced MRI. [2019]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Diffusion-Weighted MR Enterography to Monitor Bowel Inflammation after Medical Therapy in Crohn's Disease: A Prospective Longitudinal Study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Rectal cancer with complete endoscopic response after neoadjuvant therapy: what is the meaning of a positive MRI? [2022]

9. China pubmed.ncbi.nlm.nih.gov

[Diagnosis value of 3.0 T diffusion-weighted imaging with background suppression magnetic resonance for metastatic lymph nodes in rectal cancer]. [2011]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Feasibility of Simultaneous Multislice Acceleration Technique in Diffusion-Weighted Magnetic Resonance Imaging of the Rectum. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Comparison of four MRI protocols for detection of extrahepatic colorectal cancer metastases. [2019]