Ultrasound for Pancreatic Cancer

Overseen By Dorian Anglin Facey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Inability to provide consent

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 whether high-resolution ultrasound before and during surgery can help doctors better diagnose pancreatic cancer and determine if it has spread. The goal is to improve the accuracy of diagnosing pancreatic ductal adenocarcinoma and detect if the cancer has moved to other parts of the body. Suitable participants have already undergone a CT scan at UHN and are scheduled for surgery to remove pancreatic cancer. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance future diagnostic techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this high resolution ultrasound is safe for pancreatic cancer diagnosis?

Research has shown that high-resolution ultrasound is a safe tool commonly used in healthcare. In studies of a similar treatment called high-intensity focused ultrasound (HIFU), 52 patients underwent the treatment 53 times without any serious side effects. This suggests that ultrasound treatments are generally well-tolerated by patients.

Although the ultrasound method in this trial differs slightly from HIFU, the overall safety record of ultrasound treatments supports its use. Ultrasound is a non-invasive procedure, meaning it doesn't involve surgery or entering the body, which typically makes it safer and more comfortable for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using high-resolution ultrasound for pancreatic cancer because it offers a non-invasive, precise diagnostic method. Unlike traditional imaging techniques that may not clearly visualize the tumor, this advanced ultrasound provides detailed images both before and during surgery, potentially improving surgical outcomes. The ability to obtain real-time, high-definition images can help surgeons make more informed decisions, which might lead to better patient prognosis and fewer complications.

What evidence suggests that high resolution ultrasound is effective for diagnosing pancreatic cancer?

Research has shown that high-resolution ultrasound, which participants in this trial will receive, is a promising method for diagnosing pancreatic cancer. Studies have found that this ultrasound can correctly identify up to 93% of patients with the disease and accurately rule out 80% of those without it, making it highly effective in detecting pancreatic cancer. Additionally, other studies have shown that high-intensity focused ultrasound (HIFU) can help manage pain and slow tumor growth in advanced cases of pancreatic cancer. While these results are promising, more research is needed to fully understand the long-term benefits. ^{6 7 8 9 10}

Who Is on the Research Team?

Korosh Khalili, MD

Principal Investigator

UHN

Are You a Good Fit for This Trial?

This trial is for adults over 18 with pancreatic ductal adenocarcinoma, diagnosed through imaging or pathology, who have had a CT scan at UHN and are scheduled for surgery. It's not suitable for those who don't meet these specific conditions.

Inclusion Criteria

Contrast enhanced CT scan performed locally at UHN

My pancreatic cancer was confirmed by imaging or biopsy.

I am scheduled for surgery to remove a part of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo high resolution ultrasound before surgery to assess pancreatic ductal adenocarcinoma

within 2 weeks

1 visit (in-person)

Intra-operative Assessment

High resolution ultrasound is used during surgery to help diagnose pancreatic ductal adenocarcinoma and assess disease spread

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High Resolution Ultrasound

Trial Overview The study tests if high resolution ultrasound can improve the diagnosis of pancreatic cancer when used before and during surgery. The goal is to see if this method helps in assessing the spread of the disease more accurately.

How Is the Trial Designed?

Group I: High Resolution Ultasound Experimental Treatment 1 Intervention

Diagnostic high resolution ultrasound pre-operatively and intraoperatively

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

High-intensity focused ultrasound (HIFU) is a safe and non-invasive treatment option for advanced pancreatic cancer, as shown in a study of 224 cases with no severe complications reported.

While some patients experienced mild side effects like increased serum amylase levels and gastrointestinal dysfunction, the overall safety profile was positive, indicating that careful preparation and execution are essential for successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety evaluation of high-intensity focused ultrasound in patients with pancreatic cancer. Wang, K., Zhu, H., Meng, Z., et al.[2022]

Contrast-enhanced ultrasound significantly improves the accuracy of diagnosing pancreatic tumors compared to conventional ultrasonography, potentially influencing the choice of further imaging tests.

While multidetector computed tomography is the gold standard for assessing solid pancreatic lesions, MRI is better for evaluating cystic lesions and the ductal system, highlighting the importance of selecting the appropriate imaging technique based on the type of pancreatic tumor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging techniques in pancreatic tumors. D'Onofrio, M., Gallotti, A., Pozzi Mucelli, R.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11762820/

Advances in Endoscopic Ultrasound in Pancreatic Cancer ... CEH-EUS achieves a sensitivity of up to 93% and a specificity of 80% in the diagnosis of pancreatic cancer [42]. Compared to traditional EUS, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4248191/

A noninvasive therapy for locally advanced pancreatic cancer These results indicated that HIFU was a safe, non-invasive treatment. However, no long-term follow-up and survival data were reported in this study. HIFU ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.e16261

Clinical outcomes and efficacy of endoscopic ultrasound ... Clinical improvement in symptoms was reported in 11 studies and a complete resolution or decrease in tumor size was reported in 16 studies. The ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/02656736.2023.2250586

Analysis of the results of high-intensity focused ultrasound ... HIFU is safe and effective in the treatment of advanced pancreatic cancer. This approach can be used for pain control and inhibition of tumor progression in ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0301562925001863

High-Intensity Focused Ultrasound (HIFU) in Pancreatic ... Recent clinical studies conducted domestically and internationally have reported short-term pain relief rates ranging from 60% to 85% after HIFU treatment [15, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4110591/

Safety trial of high-intensity focused ultrasound therapy for ... CONCLUSION: We suggest that HIFU therapy is safe and has the potential to be a new method of combination therapy for PC. Keywords: High-intensity focused ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2019.37.4_suppl.339

Safety and efficacy of high-intensity focused ultrasound in ... Results: High-intensity focused ultrasound treatment was performed without severe adverse event in 52 patients, 53 times (male/female = 28/24; ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4099025/

High-Intensity Focused Ultrasound Treatment for Advanced ... Overall 1-, 3-, and 5-year survival of pancreatic cancer patients are 16%, 5%, and 4%, respectively [5]. Therefore, alternative solution for ...

9. tandfonline.com tandfonline.com/doi/full/10.1080/02656736.2023.2295812

US-guided high-intensity focused ultrasound in pancreatic ... Ultrasound-guided high-intensity focused ultrasound is a safe and effective noninvasive palliative treatment option for patients with inoperable ...

10. fusfoundation.org fusfoundation.org/posts/focused-ultrasound-for-pancreatic-cancer-trial-results-prove-safety-initial-efficacy/

Trial Results Prove Safety, Initial Efficacy Early, proof-of-concept safety data and the protocol parameters from a pancreatic cancer focused ultrasound plus chemotherapy clinical trial ...