Ultrasound Imaging for Pancreatic Cancer

Overseen By Jessica Scott, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Inability to tolerate contrast, others

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

Compensation: Varies

Number of Visits: 2

19 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Ultrasound Imaging Technique for pancreatic cancer?

Ultrasound imaging has been shown to be a sensitive and specific method for detecting pancreatic cancer, with a study reporting 100% sensitivity in identifying the condition. Additionally, ultrasound imaging during pancreatic surgery has been found useful in defining the pathology and aiding surgeons in 66% of operations for tumors. ^{1 2 3 4 5}

Is ultrasound imaging safe for humans?

Ultrasound imaging, including techniques like contrast-enhanced ultrasound (CEUS) and high-intensity focused ultrasound (HIFU), has been shown to be safe in humans. CEUS is already approved for use in liver and kidney conditions, and studies suggest it is safe for both adults and children. HIFU has been evaluated for safety in treating pancreatic cancer, indicating it is generally safe for human use. ^{6 7 8 9 10}

How does ultrasound imaging differ from other treatments for pancreatic cancer?

Ultrasound imaging is unique because it is a noninvasive and nonionizing technique that directly images the pancreas, making it a primary screening tool for pancreatic cancer. Unlike other treatments, it helps in the early detection and staging of pancreatic tumors without the need for invasive procedures. ^{2 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to see if ultrasound images that are analyzed by a special computer program can be used to measure the size of PDAC tumors in the liver as accurately as CT scans that involve contrast material (also called contrast-enhanced CT scans). All participants in this study will have pancreatic ductal adenocarcinoma (PDAC) that has spread (metastasized) to the liver, and all participants will be scheduled for a routine CT scan that will measure their cancer.

Research Team

Kinh Gian Do, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with pancreatic ductal adenocarcinoma (PDAC) or gastrointestinal (GI) adenocarcinoma that has spread to the liver. They must be scheduled for a routine CT scan. People can't join if they can't handle IV contrast, have very small liver metastases, or if their liver is more than half taken up by tumors.

Inclusion Criteria

I am scheduled for a CT scan with contrast.

My cancer started in the pancreas or GI tract and has spread to my liver.

Exclusion Criteria

My liver cancer spots are all 10 mm or smaller.

You can't handle the injection of contrast dye into your veins.

More than half of my liver is affected by cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Imaging

Participants undergo research ultrasound (rUS1) within three days of their routine contrast-enhanced CT scan (CECT)

1 week

1 visit (in-person)

Follow-up Imaging

A subset of participants undergo a second research ultrasound (rUS2) at 3-4 weeks after rUS1

3-4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

1 year

Treatment Details

Interventions

• Ultrasound Imaging Technique

Trial Overview The study tests whether a special computer program analyzing ultrasound images can measure PDAC tumors in the liver as accurately as regular contrast-enhanced CT scans.

Participant Groups

Group I: research ultrasound (rUS1) Experimental Treatment 1 Intervention

Participants will undergo research ultrasound (rUS1) within three days of their routine contrast enhanced CT scan (CECT). A subset of participants (up to 10) will undergo a second research US (rUS2) at 3-4 weeks after rUS1 and at least one month prior to the next planned clinical CECT.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

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]

References

1. Cyprus pubmed.ncbi.nlm.nih.gov

Ultrasound combined with computed tomography in pancreatic cancer. [2020]

2. Italy pubmed.ncbi.nlm.nih.gov

[Echography in patients with clinically suspected pancreatic carcinoma. Analysis of a prospective study]. [2008]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical application of dynamic contrast enhanced ultrasound in monitoring the treatment response of chemoradiotherapy of pancreatic ductal adenocarcinoma. [2023]

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

The role of imaging ultrasound during pancreatic surgery. [2019]

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

Gray-scale and color flow sonography of pancreatic ductal adenocarcinoma. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

The efficacy of a new high intensity focused ultrasound therapy for locally advanced pancreatic cancer. [2022]

7. Greece pubmed.ncbi.nlm.nih.gov

High intensity focused ultrasound treatment for patients with local advanced pancreatic cancer. [2022]

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

Diagnosing Pancreatic Adenocarcinoma With Contrast-Enhanced Ultrasonography: A Literature Review of Research in Europe and Asia. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Safety evaluation of high-intensity focused ultrasound in patients with pancreatic cancer. [2022]

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

Thermal Ablation of the Pancreas With Intraoperative High-Intensity Focused Ultrasound: Safety and Efficacy in a Porcine Model. [2018]

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

Ultrasonic evaluation of the pancreas. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

[Doppler echography for the preoperative assessment of malignant processes in the pancreas head and liver hilus]. [2016]

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

Ultrasonography of the pancreas. 1. Conventional imaging. [2016]

14. England pubmed.ncbi.nlm.nih.gov

Imaging techniques in pancreatic tumors. [2022]