Multiparametric Ultrasound for Cancer

Recruiting at 6 trial locations

Overseen By Wyanne Law, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Nursing, Under 18, others

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

Compensation: Varies

Number of Visits: 1

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new type of ultrasound called multiparametric ultrasound (mpUS) to determine if it can better evaluate cancer and other tissue issues. Unlike standard ultrasounds, mpUS combines several imaging techniques to provide a detailed view of tissue, revealing aspects like blood flow and microstructure. The study includes individuals at high risk for pancreatic cancer, those with pancreatic cancer, or those with thyroid nodules requiring a biopsy. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance diagnostic techniques for future patients.

Do I need to stop my current medications to join 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 multiparametric ultrasound imaging is safe for cancer assessment?

Research has shown that multiparametric ultrasound (mpUS) is generally safe for humans. For individuals with pancreatic ductal adenocarcinoma, studies have indicated that endoscopic ultrasound (a type of internal ultrasound) has been safe and effective since the 1990s, with high diagnostic accuracy. This suggests it is usually well-tolerated.

Experts recommend mpUS for thyroid nodules because it enhances nodule assessment, reflecting confidence in its safety. Similarly, for those at high risk for pancreatic cancer, endoscopic ultrasound has proven to be a safe and effective method.

Overall, these findings suggest that mpUS is well-tolerated, with no major safety concerns reported in the reviewed studies. However, discussing any potential risks with healthcare providers is important when considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using multiparametric ultrasound (mpUS) because it could revolutionize how we detect and assess certain cancers. Unlike traditional ultrasound, which provides a single type of image, mpUS combines multiple imaging techniques to offer a more detailed and comprehensive view of tissues. This method could improve the accuracy of diagnosing conditions like pancreatic ductal adenocarcinoma and thyroid nodules by providing enhanced detail without significantly increasing the procedure time. By integrating mpUS into standard care, doctors hope to catch cancer earlier and with greater precision, potentially leading to better treatment outcomes.

What evidence suggests that multiparametric ultrasound imaging is effective for evaluating cancer?

Research shows that multiparametric ultrasound (mpUS) could be a powerful tool for evaluating cancer. In this trial, participants will undergo different mpUS imaging procedures based on their condition. For those with pancreatic ductal adenocarcinoma, multiparametric endoscopic ultrasound (mpEUS) will be used. Studies have found endoscopic ultrasound to be very accurate, with a sensitivity of 91–100% for detecting the disease, even for small tumors. Participants with thyroid nodules will undergo mpUS imaging, which has a sensitivity of 85% and a specificity of 80%, aiding in correctly identifying potentially cancerous nodules. For individuals at high risk for pancreatic cancer, mpEUS imaging will be utilized, as it has shown a sensitivity of up to 93% and a specificity of 80%, making it a promising option for early detection. Overall, mpUS combines different ultrasound techniques to provide a more detailed and accurate view of tissues, potentially improving the diagnosis of various cancers. ^{1 4 5 6 7}

Who Is on the Research Team?

Mark T Burgess, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with pancreatic cancer or thyroid nodules. Participants should be suitable candidates for ultrasound imaging and willing to undergo mpUS as well as standard tests. Specific eligibility details are not provided, so interested parties should inquire further.

Inclusion Criteria

I am at risk for pancreatic cancer due to family history but do not have it.

I am having a biopsy for a thyroid nodule guided by ultrasound.

Cohort 1 - Feasibility of multiparametric endoscopic ultrasound (mpEUS) imaging of patients at high-risk for pancreatic cancer: Patients enrolled into the Memorial Sloan Kettering Cancer Center Pancreatic Registry protocol (IRB#: 02-102) who are at high risk of pancreatic cancer

Exclusion Criteria

I am over 18, live in the continental US, and can sign a consent form.

I am over 18, live in the continental US, and can sign a consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants undergo add-on mpUS or mpEUS imaging during their standard ultrasound or EUS procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multiparametric Ultrasound Imaging

Trial Overview The study is testing multiparametric ultrasound (mpUS) imaging against standard ultrasound methods in evaluating cancerous and non-cancerous tissue in the pancreas and thyroid. The goal is to determine if mpUS provides more detailed information about blood vessels, flow, and microstructure.

How Is the Trial Designed?

Group I: Thyroid nodule assessment with multiparametric ultrasound (mpUS) imaging Experimental Treatment 1 Intervention

Subjects will undergo add-on mpUS imaging at the beginning of their standard of care ultrasound procedure and will add up to approximately 5 minutes of added scan time.

Group II: Multiparametric endoscopic (mpEUS) imaging of patients with pancreatic ductal adenocarcinoma Experimental Treatment 1 Intervention

Subjects will undergo add-on mpEUS imaging during their standard EUS procedure and will add up to approximately 15 minutes of added scan time.

Group III: Multiparametric endoscopic (mpEUS) imaging of patients at high-risk for pancreatic cancer Experimental Treatment 1 Intervention

Subjects will undergo add-on mpEUS imaging during their standard of care EUS imaging and will add up to approximately 15 minutes of added scan time.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07270237

A Study of Multiparametric Ultrasound Imaging Methods The researchers are doing this study to see how well a type of ultrasound imaging called multiparametric ultrasound (mpUS), can be used to ...

2. 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, ...

3. journals.lww.com journals.lww.com/eusjournal/fulltext/2023/01000/role_of_eus_combined_with_a_newly_modified_scoring.14.aspx

Role of EUS combined with a newly modified scoring ... Benefit of surveillance for pancreatic cancer in high-risk individuals:Outcome of long-term prospective follow-up studies from three European expert centers.

4. mdpi.com mdpi.com/2227-9059/13/7/1733

Early Detection of Pancreatic Cancer: Current Advances ... While pancreas-protocol MDCT achieves a high sensitivity of approximately 89% for overt PDAC [86], its sensitivity declines sharply for small tumors (<2 cm), ...

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

Multiparametric detection and outcome prediction of ... Our reported multiparametric approach allowed for accurate discrimination of pancreatic cancer and revealed great potential to provide ...

6. reporter.nih.gov reporter.nih.gov/search/vq_--B2uY0yTvBaJy0mkCQ/project-details/11034663

Project Details Multiparametric endoscopic ultrasound offers a non-subjective, quantitative approach for detection and characterization of pancreatic cancer. Ultimately, this ...

7. journals.lww.com journals.lww.com/eusjournal/fulltext/2016/05010/the_role_of_endoscopic_ultrasound_in_pancreatic.3.aspx

The role of endoscopic ultrasound in pancreatic cancer... Since its first use in the early 1990s, it has evolved into an efficient technique with good safety profile and high diagnostic accuracy ranging 80%-90%.