MRI Scanning for Pancreatic Cancer Detection

(DWI-PDAC Trial)

No longer recruiting at 1 trial location

Overseen By Alexandre Brind'Amour, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Disqualifiers: Locally advanced disease, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to detect cancer spread in individuals with pancreatic cancer. It employs a type of MRI scan called whole-body diffusion-weighted MRI, which may surpass the usual CT scans in identifying cancer spread to the abdominal lining. The trial targets individuals with a confirmed diagnosis of pancreatic ductal adenocarcinoma, a tumor size of 3 cm or more, and a specific blood marker level (CA 19-9) of 400 or higher. Participants should not exhibit signs of cancer spread to other body parts and must be healthy enough for surgery. The goal is to determine if this MRI scan provides more useful information than a CT scan before surgery. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cancer detection methods.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this MRI technique is safe for detecting pancreatic cancer?

Research has shown that whole-body diffusion-weighted magnetic resonance imaging (DWI/MRI) is generally safe and well-tolerated. Studies have found it useful for cancer screening, particularly for individuals at high risk of certain cancers. It is already recommended for screening in adults and children with an increased risk of developing cancer.

While specific safety data for pancreatic cancer is limited, previous studies demonstrated its effectiveness in detecting cancer spread to the liver in pancreatic cancer patients. This suggests that the imaging process is safe for use in serious medical conditions.

Overall, DWI/MRI does not use radiation, unlike other imaging methods such as CT scans, making it a safer option for repeated use. No specific negative effects have been reported in the sources provided, indicating a strong safety profile for this imaging technique. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using whole-body diffusion-weighted magnetic resonance imaging (DWI-MRI) for pancreatic cancer detection because it offers a non-invasive and comprehensive way to detect cancerous changes in the body. Unlike traditional imaging techniques such as CT scans or standard MRIs, DWI-MRI provides detailed insights into tissue density and cellular structure, which can help identify tumors at an earlier stage. This method could potentially lead to earlier diagnosis and treatment, improving outcomes for patients with pancreatic cancer.

What evidence suggests that this MRI scanning technique is effective for detecting pancreatic cancer?

Research has shown that a special type of full-body scan, called DWI/MRI, excels at detecting pancreatic cancer. In this trial, participants will undergo DWI-MRI to evaluate its effectiveness in identifying pancreatic cancer. Studies have found that this scan is highly accurate, correctly identifying cancerous tissue. One study showed it detected cancer 96.2% of the time and correctly identified healthy tissue 98.6% of the time. This makes DWI/MRI reliable for distinguishing between cancerous and healthy tissue. By providing clear images, it helps doctors determine if the cancer has spread, which is crucial for planning treatment. ^{4 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 individuals with confirmed pancreatic ductal adenocarcinoma that can potentially be removed by surgery. They should have a tumor size of at least 3 cm and elevated CA 19-9 levels without distant metastases. Participants must be physically fit enough for pancreatic resection (ECOG performance status of 0 or 1).

Inclusion Criteria

My CA 19-9 levels are high, but my bilirubin is normal.

My tumor is larger than 3 cm.

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

Exclusion Criteria

You cannot have an MRI scan.

There is a suspicion that cancer has spread to other parts of the body, as seen on a CT scan.

I am not fit for pancreatic 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 whole-body DWI/MRI within 4 weeks of planned surgery to assess for peritoneal metastases

4 weeks

1 visit (in-person)

Surgical Evaluation

Participants with no evidence of PM on WB-DWI/MRI undergo pancreatic resection; those with suspicion of PM undergo diagnostic laparoscopy first

1-2 weeks

Follow-up

Participants are monitored for early distant recurrence and unexpected aborted surgery due to peritoneal metastases discovery

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Whole-body diffusion-weighted magnetic resonance imaging

Trial Overview The study is testing the effectiveness of whole-body diffusion-weighted MRI in detecting peritoneal metastases in patients with high-risk pancreatic cancer, comparing its results to those from CT scans and correlating them with findings during surgery.

How Is the Trial Designed?

Group I: DWI-MRI Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10114410/

Multiparametric detection and outcome prediction of ... Diagnostic performance of dual-energy CT, MRI, and radiomics features to discriminate between malignant and inflamed pancreatic tissue.

2. wjgnet.com wjgnet.com/1949-8470/full/v17/i10/112271.htm

Diffusion-weighted magnetic resonance imaging of the ... Rosenkrantz et al[89] reported that the subjective image quality of abdominal DWI at 3.0-T is significantly inferior to that at 1.5-T. However, ...

3. ajronline.org ajronline.org/doi/10.2214/AJR.05.1918

High-b Value Diffusion-Weighted MRI for Detecting Pancreatic ... The mean sensitivity and specificity for the detection of pancreatic adenocarcinoma were 96.2% and 98.6%, respectively. The kappa values indicating ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0378603X15000662

Differentiation of Pancreatic lesions using Diffusion- ... Mean ADC values of malignant lesions were significantly lower than those of benign lesions. DWI has a similar accuracy to MRI-c in diagnosis of pancreas cancer.

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.637681/full

Diagnostic Performance of Diffusion-Weighted Imaging for ... Our study demonstrated that DWI can accurately differentiate malignant potential of pancreatic IPMNs with overall pooled sensitivity of 74%, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4620112/

Diffusion-weighted imaging of pancreatic cancer - PMC Thanks to its high negative prognostic value, DWI should be used to assess the presence of liver metastases in patients with pancreatic adenocarcinoma.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8558201/

Whole-body magnetic resonance imaging (WB-MRI) for ... Whole-body magnetic resonance imaging (WB-MRI) is currently recommended for cancer screening in adult and paediatric subjects with cancer predisposition ...

8. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.11110474

Whole-Body Diffusion-weighted MR Imaging in Cancer Because whole-body DW imaging excels at bone marrow assessments at diagnosis and for therapy response, it can potentially address a number of ...

9. dirjournal.org dirjournal.org/pdf/beb8919b-f013-4ea1-b1c8-40332e840fe1/articles/1305-3825.DIR.4708-11.2/Diagn%20Interv%20Radiol-18-46-En.pdf

Diffusion-weighted MRI for detecting and monitoring cancer In this article, we review the basic concepts, imaging strategies, and body applications of diffusion-weighted MRI in detecting and monitoring ...