3D-MPUS for Liver Cancer

(3DMPUS Trial)

Not currently recruiting at 2 trial locations

Overseen By David Marcellus, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Severe reaction to ultrasound contrast, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

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 imaging method called 3D-MPUS (3D Multi-Parametric Ultrasound) to evaluate its effectiveness in aiding doctors' treatment decisions for liver tumors. The goal is to use this advanced ultrasound technique to monitor liver cancer patients' responses to therapy early in their treatment. Individuals diagnosed with untreated liver metastases from colorectal cancer who are beginning a new therapy course may qualify for this study. Participants will undergo 3D-MPUS imaging, which involves a brief ultrasound procedure with a contrast agent. As an unphased study, this trial offers an opportunity to contribute to innovative research that could enhance future cancer treatment strategies.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems that you can continue your existing cancer therapy, as the trial allows for any line of cancer treatment.

What prior data suggests that 3D-MPUS is safe for liver cancer patients?

Research shows that 3-dimensional multi-parametric ultrasound (3D-MPUS) for liver cancer imaging is generally well-tolerated. Studies on similar ultrasound methods indicate that they clearly and accurately display liver tumor details and blood flow differences, aiding doctors in understanding the tumor without causing harm.

Participants in these studies usually receive a contrast agent called sulfur hexafluoride through an IV. This agent is considered safe and enhances image quality. Most people do not experience any serious side effects from it.

Overall, 3D-MPUS for liver cancer imaging has shown promise in safely assisting doctors in making better treatment decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 3D-MPUS for liver cancer because it offers a new way to visualize tumors using 3-dimensional multi-parametric ultrasound imaging. Unlike traditional imaging methods like CT or MRI scans, this technique uses sulfur hexafluoride IV to enhance the ultrasound, providing a detailed, real-time look at the liver's structure and function. This could lead to earlier detection and more precise treatment planning, potentially improving patient outcomes without the need for radiation exposure.

What evidence suggests that 3D-MPUS is effective for liver cancer?

Research has shown that 3D multi-parametric ultrasound (3D-MPUS), which participants in this trial will undergo, serves as a useful tool for understanding liver tumors. Studies indicate that this imaging method provides clear and accurate pictures of liver tumors and helps identify differences in blood flow. This capability is important because it can assist doctors in making better treatment decisions. Previous findings suggest that 3D-MPUS can detect changes in liver tumors early, which is crucial for evaluating treatment effectiveness. This method offers doctors a real-time view of how the tumor responds to treatment, which is valuable for ongoing care. ^{2 3 4 5 6}

Who Is on the Research Team?

Aya Kamaya, MD

Principal Investigator

Stanford University

Aman Khurana, MD

Principal Investigator

University of California, San Diego

Yuko Kono, MD, PhD, FAIUM, FAASLD

Principal Investigator

University of California, San Diego

Andrej Lyshchik, MD, PhD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with liver tumors who are starting a new treatment. They must have at least one tumor between 1cm and 14cm, be willing to follow the study rules, and able to give informed consent. It's not for those with severe allergies to contrast media used in ultrasounds or CT scans, pregnant or breastfeeding women, people with certain heart conditions, kidney issues (creatinine >1.5mg/dl), or uncontrolled high blood pressure.

Inclusion Criteria

I can understand and am willing to sign the consent form.

Participant is willing to comply with protocol requirements

I am starting treatment for liver cancer soon.

Exclusion Criteria

My creatinine level is above 1.5mg/dl, indicating kidney issues.

My high blood pressure is not under control.

Participant has documented anaphylactic or other severe reactions to any ultrasound or CT contrast media

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo baseline 3D-MPUS imaging to acquire initial diagnostic data

1 day

1 visit (in-person)

Treatment Monitoring

Continuous and dynamic imaging of patients undergoing therapy to monitor early-phase treatment response

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3D-MPUS

Trial Overview The trial is testing how well a new imaging technique called 3D multi-parametric ultrasound (3D-MPUS) helps in making treatment decisions for liver cancer patients. This method could provide additional functional information about the tumor during therapy that current methods don't offer.

How Is the Trial Designed?

Group I: 3-dimensional multi-parametric ultrasound imaging (3D-MPUS) Experimental Treatment 1 Intervention

Participants will receive sulfur hexafluoride IV and undergo 3D-MPUS imaging over 20 minutes.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Parametric imaging with contrast-enhanced ultrasound (CEUS) effectively differentiates hepatocellular carcinoma (HCC) from metastatic liver cancer (MLC), showing significant differences in maximum intensity and washout time between the two types of cancer.

The study, which included 30 HCC and 30 MLC cases, found that a washout time cut-off of 43.765 seconds provided a diagnostic accuracy of 78.4%, with a sensitivity of 84.6% and specificity of 72.0%, indicating its potential as a reliable parameter for diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parametric imaging with contrast-enhanced ultrasound for differentiating hepatocellular carcinoma from metastatic liver cancer. Yue, WW., Wang, S., Xu, HX., et al.[2022]

The study reanalyzed inconclusive focal liver lesions (FLLs) using a multiparametric ultrasound (MPUS) approach, achieving a classification accuracy of 78% for determining whether lesions were malignant or benign.

The analysis revealed that the area parameter from time-intensity curve analysis (TIC) was significant in differentiating between malignant and benign lesions, indicating that MPUS can enhance diagnostic capabilities for liver lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric Ultrasound Approach Using a Tree-Based Decision Classifier for Inconclusive Focal Liver Lesions Evaluated by Contrast Enhanced Ultrasound. Moga, TV., David, C., Popescu, A., et al.[2021]

In a study involving 102 focal liver lesions in 92 patients, 3D contrast-enhanced ultrasound (3D-CEUS) demonstrated significantly better image quality and diagnostic confidence for evaluating local treatment responses compared to characterizing lesions, with a visualization rate of 94.1% in treatment evaluations versus 72.6% in characterization.

While factors like lesion diameter and location did not significantly affect image quality, 3D-CEUS improved diagnostic confidence in 80.4% of treatment response evaluations, suggesting its potential as a valuable tool in clinical settings for monitoring liver lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional contrast-enhanced ultrasound of the liver: experience of 92 cases. Xu, HX., Lu, MD., Xie, XH., et al.[2022]

In a study involving 76 patients with 95 liver tumors, 3D ultrasound/contrast-enhanced ultrasound (3D US-CEUS) fusion imaging demonstrated a high registration success rate of 93.7%, allowing for effective immediate evaluation during thermal ablation procedures.

The technique showed a remarkable effectiveness rate of 98.8% for the ablation, with no major complications reported, highlighting its safety and efficacy in guiding supplementary treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate evaluation and guidance of liver cancer thermal ablation by three-dimensional ultrasound/contrast-enhanced ultrasound fusion imaging. Xu, EJ., Lv, SM., Li, K., et al.[2022]

Combining different ultrasound modalities, such as greyscale ultrasound and Doppler techniques, can significantly enhance diagnostic performance, improving sensitivity by 13-51% in some cases.

Despite the promising results, there is a lack of standardized systems for combining these modalities, similar to the PIRADS system used in mpMRI, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric ultrasound in the detection of prostate cancer: a systematic review. Postema, A., Mischi, M., de la Rosette, J., et al.[2022]

The study involved 142 patients with various liver tumors and demonstrated that contrast-enhanced multiphase dynamic ultrasonography (US) achieved an overall diagnostic accuracy of 93.7%.

This method showed excellent sensitivity and specificity for different types of liver tumors, including 100% sensitivity for hepatocellular carcinoma (HCC), indicating it is a highly effective and safe tool for liver tumor characterization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-enhanced multiphase dynamic ultrasonography for the characterization of liver tumors. Tanaka, S., Hamada, Y., Ioka, T., et al.[2018]

Three-dimensional power Doppler ultrasonography can definitively diagnose hepatocellular carcinoma in 56% of examined nodules, providing a real-time and non-invasive diagnostic method.

The technique is particularly effective for larger nodules (over 2 cm) and those with specific vascular patterns (Types 2-4), while smaller nodules or those in certain locations may not yield specific results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional power Doppler ultrasonography for hepatocellular carcinoma: a comparison with angiography? Sato, S., Yoshida, H., Teratani, T., et al.[2006]

The study involving 24 patients demonstrated that 3D contrast-enhanced ultrasound (CEUS) fusion imaging has a high success rate of 95.8% and a short average fusion time of about 4.1 minutes, making it a practical tool for evaluating safety margins after microwave ablation of hepatocellular carcinoma (HCC).

3D CEUS fusion imaging showed excellent agreement with contrast-enhanced computed tomography (CECT) in assessing ablation margins, with a kappa value of 0.911, indicating that it is a reliable method for determining the efficacy of thermal ablation in HCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel mono-modality fusion imaging method based on three-dimensional contrast-enhanced ultrasound for the evaluation of ablation margins after microwave ablation of hepatocellular carcinoma. Ding, J., Wang, D., Zhou, Y., et al.[2022]

3D ultrasonography enhances the detection and assessment of liver tumors compared to traditional 2D ultrasonography, offering improved efficiency and accuracy in locating tumors and measuring their size relative to important liver structures.

This advanced imaging technique not only aids in the initial screening of liver tumors but also plays a crucial role in monitoring tumor characteristics and volume during post-chemotherapy follow-up, making it a valuable tool in liver cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the liver tumors using three-dimensional ultrasonography. A pictorial essay. Badea, R., Socaciu, M., Lupşor, M., et al.[2016]

Microfocused Ultrasound with Visualization (MFU-V) has a well-established safety profile, showing only mild and transient side effects like tenderness and redness, with rare adverse events typically linked to improper technique.

When used correctly, MFU-V treatments are safe, with most side effects resolving quickly and without lasting effects, indicating its efficacy in cosmetic dermatology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. Hitchcock, TM., Dobke, MK.[2022]

Multiparametric ultrasound (MPUS) is an effective, non-invasive tool for diagnosing liver diseases, providing real-time assessments and reducing the need for more invasive procedures.

MPUS can accurately stage liver fibrosis, detect portal hypertension and esophageal varices, and characterize focal liver lesions, making it a valuable resource in hepatology for improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiparametric ultrasound in liver diseases: an overview for the practising clinician. Grgurevic, I., Tjesic Drinkovic, I., Pinzani, M.[2020]

In a study involving 23,188 abdominal examinations using the ultrasound contrast agent SonoVue, only 29 adverse events (AEs) were reported, indicating a very low incidence of complications.

The overall rate of serious adverse events was extremely low at 0.0086%, and SonoVue demonstrated a good safety profile, comparable to or better than other contrast agents used in radiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. Piscaglia, F., Bolondi, L.[2022]

In a study involving 95 patients with liver cancer, 3D contrast-enhanced ultrasound (3D-CEUS) provided high image quality in 95.3% of lesions, enhancing diagnostic confidence without changing the diagnosis compared to traditional 2D ultrasound.

3D-CEUS influenced treatment management in 2.8% of cases, indicating its potential usefulness in evaluating treatment responses for liver cancer after local therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment response evaluation with three-dimensional contrast-enhanced ultrasound for liver cancer after local therapies. Xu, HX., Lu, MD., Xie, XH., et al.[2022]

In a study of 300 high-risk patients for hepatic malignant tumors, contrast-enhanced ultrasonography (CEUS) detected 94.1% of malignant lesions, significantly outperforming unenhanced ultrasonography (US) which detected only 79.8%.

CEUS demonstrated a high diagnostic accuracy of 91.6% for differentiating liver lesions, compared to 59.1% for US, indicating that CEUS is a reliable and effective first-line method for assessing high-risk populations for hepatic malignant tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application value of contrast-enhanced ultrasonography for assessing the high-risk population of hepatic malignant tumor]. Lyu, P., Li, S., Xu, H., et al.[2018]

Citations

1. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT05705219

Development of 3D Multi-Parametric Ultrasound (MPUS) as a ... This clinical trial studies how well 3-dimensional multi-parametric ultrasound (3D MPUS) imaging works as a decision-support tool for patients with liver tumors ...

2. withpower.com withpower.com/trial/phase-carcinoma-hepatocellular-2-2023-b0bf6?condition=HCC&overallStatus=Recruiting&hasNoPlacebo=false

3D-MPUS for Liver Cancer (3DMPUS Trial) This clinical trial studies how well 3-dimensional multi-parametric ultrasound (3D MPUS) imaging works as a decision-support tool for patients with liver ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11106354/

Ultrasonography of Hepatocellular Carcinoma This article is a comprehensive overview of ultrasound technology in the treatment of HCC, encompassing early detection, diagnosis, staging, treatment ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899707115003162

Clinical value of dynamic 3-dimensional contrast ... It has been demonstrated that CEUS is able to display the characteristics of liver tumors clearly and accurately, as well as the perfusion differences between ...

5. nature.com nature.com/articles/s41598-021-82153-z

Multiparametric ultrasound imaging for the assessment of ... We present here a multiparametric ultrasound (mpUS) imaging approach for assessing nonalcoholic fatty liver disease (NALFD).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9406360/

Current Imaging Diagnosis of Hepatocellular Carcinoma - PMC This review will describe and discuss all these imaging modalities and their advances in the imaging of HCC lesions in cirrhotic and non-cirrhotic livers.