DWI/MRI for Detecting Colorectal and Appendiceal Cancer

(DWI-HighRisk Trial)

Not currently recruiting at 3 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of MRI called whole-body diffusion-weighted MRI to determine if it can better detect cancer spread in the abdominal area for individuals with colorectal or certain types of appendix cancer. The goal is to assess whether this MRI can identify cancer that might return after surgery, particularly in those with specific high-risk indicators, such as previous cancer spread to the ovaries or a ruptured tumor. Suitable participants have undergone surgery for colorectal or certain appendix cancers and exhibit these high-risk features, but have no cancer spread beyond the abdomen. As an unphased trial, this study allows patients to contribute to innovative research that could enhance cancer detection methods.

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 prior data suggests that this imaging technique is safe for detecting peritoneal metastases?

Research has shown that whole-body diffusion-weighted magnetic resonance imaging (DWI/MRI) reliably and accurately diagnoses colorectal cancer. Studies have found it highly effective in detecting cancer spread with great accuracy. Importantly, DWI/MRI is non-invasive, requiring no surgery or body entry.

DWI/MRI presents no major safety concerns. Unlike CT scans, it does not use radiation, making it safer for repeated use. Studies have not reported any major side effects with DWI/MRI. In summary, DWI/MRI is considered a safe and well-tolerated method for detecting cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about whole-body diffusion-weighted magnetic resonance imaging (DWI-MRI) for colorectal and appendiceal cancer because it offers a non-invasive way to detect these cancers with potentially greater precision. Unlike traditional imaging methods like CT scans, DWI-MRI doesn't use ionizing radiation, making it safer for patients over time. This technique could provide clearer images for better diagnosis and staging, which is crucial for planning effective treatment strategies. If successful, this approach may lead to earlier and more accurate detection, improving patient outcomes.

What evidence suggests that DWI/MRI is effective for detecting peritoneal metastases in colorectal and appendiceal cancer?

Research has shown that whole-body diffusion-weighted magnetic resonance imaging (DWI/MRI), which participants in this trial will undergo, effectively detects colorectal and appendiceal cancer. Studies have demonstrated that DWI/MRI excels in correctly identifying cancer (high sensitivity) and avoiding false positives (high specificity). Compared to CT scans, DWI/MRI better detects cancer spread within the abdomen in patients with colorectal and gynecological cancers. In some cases, it also identified additional issues that other imaging methods missed. This suggests that DWI/MRI could be a valuable tool for tracking cancer spread and aiding treatment decisions. ^{1 6 7 8 9}

Who Is on the Research Team?

Alexandre Brind'Amour, MD

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05623787

NCT05623787 | Diagnostic Value of Diffusion-weighted ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9260027/

Diagnostic Performance of Diffusion-Weighted Imaging for ... The performance of DWI-MRI for diagnosing colorectal cancer was accurate, with pooled sensitivity, specificity, positive likelihood ratio, and negative ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0959804911003467

Whole-body diffusion-weighted magnetic resonance imaging This article aims to review the current evidence for whole-body diffusion-weighted MR imaging in oncology, to discuss its potential for the staging of (colo) ...

4. withpower.com withpower.com/trial/dwimri-for-detecting-colorectal-and-appendiceal-cancer-797bc

DWI/MRI 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 ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/codi.16840

Whole‐body MRI with diffusion‐weighted imaging as an ... Whole-body MRI including diffusion-weighted imaging (DW-MRI) resulted in discrepant/additional findings in 26/55 (47%) cases; 23/37 (62%) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4694225/

Meta-analysis of diffusion-weighted magnetic resonance ... Conclusions: Our meta-analysis indicates that DWI is a highly accurate diagnostic method in identification of colorectal cancer. Keywords: MRI, diffusion ...

7. researchgate.net researchgate.net/publication/51211209_Whole-body_diffusion-weighted_magnetic_resonance_imaging_Current_evidence_in_oncology_and_potential_role_in_colorectal_cancer_staging

Whole-body diffusion-weighted magnetic resonance imaging The major strength of PET/CT is the detection of distant colorectal cancer metastases with an accuracy of up to 97 % [8][9][10]. ... ... The ...

8. ajronline.org ajronline.org/doi/10.2214/AJR.11.7866

Whole-Body Diffusion-Weighted MRI: Tips, Tricks, and Pitfalls Whole-body diffusion-weighted MRI can be used for tumor staging and assessment of treatment response. Meticulous technique and knowledge of potential ...

9. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.656095/full

Diagnostic Performance of Diffusion-Weighted Imaging for ... The performance of DWI-MRI for diagnosing colorectal cancer was accurate, with pooled sensitivity, specificity, positive likelihood ratio, and negative ...