3D-MPUS for Liver Cancer

(3DMPUS Trial)

Recruiting at 1 trial location

Overseen By David Marcellus, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

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

80 Participants Needed

Trial Summary

What is the purpose of this 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 tumors undergoing therapy. Continuous and dynamic imaging of patients undergoing therapy is required to monitor early-phase treatment response. 3D-MPUS is an inexpensive and safe method, which may provide complementary quantitative functional (perfusion) and tissue characterization information to anatomical radiological assessment or blood biomarkers.

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 data supports the effectiveness of the treatment 3D-MPUS for liver cancer?

Research shows that three-dimensional contrast-enhanced ultrasound (3D-CEUS) is useful in evaluating how well liver cancer treatments are working and guiding additional procedures, which suggests that similar 3D ultrasound techniques like 3D-MPUS could be effective in managing liver cancer. ^{1 2 3 4 5}

Is 3D-MPUS safe for use in humans?

The safety of 3D-MPUS, which involves ultrasound imaging techniques, is generally good. A large study on a similar ultrasound contrast agent, SonoVue, used in abdominal exams, showed a very low rate of serious side effects, with most being mild and temporary. ^{2 6 7 8 9}

How is the 3D-MPUS treatment for liver cancer different from other treatments?

The 3D-MPUS treatment for liver cancer is unique because it uses advanced three-dimensional ultrasound technology to provide a detailed and non-invasive assessment of liver tumors. This approach allows for precise tumor localization and characterization, improving the efficiency of screening and follow-up compared to traditional imaging methods. ^{10 11 12 13 14}

Research Team

Aya Kamaya, MD

Principal Investigator

Stanford University

Andrej Lyshchik, MD, PhD

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

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 am starting treatment for liver cancer soon.

Participant is willing to comply with protocol requirements

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

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

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

Treatment Details

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.

Participant Groups

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?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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 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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Treatment response evaluation with three-dimensional contrast-enhanced ultrasound for liver cancer after local therapies. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Immediate evaluation and guidance of liver cancer thermal ablation by three-dimensional ultrasound/contrast-enhanced ultrasound fusion imaging. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

Contrast-enhanced multiphase dynamic ultrasonography for the characterization of liver tumors. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Parametric imaging with contrast-enhanced ultrasound for differentiating hepatocellular carcinoma from metastatic liver cancer. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Application value of contrast-enhanced ultrasonography for assessing the high-risk population of hepatic malignant tumor]. [2018]

6. China 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Three-dimensional contrast-enhanced ultrasound of the liver: experience of 92 cases. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Review of the safety profile for microfocused ultrasound with visualization. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Multiparametric Ultrasound Approach Using a Tree-Based Decision Classifier for Inconclusive Focal Liver Lesions Evaluated by Contrast Enhanced Ultrasound. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Multiparametric ultrasound in liver diseases: an overview for the practising clinician. [2020]

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

Multiparametric ultrasound in the detection of prostate cancer: a systematic review. [2022]

13. Romania pubmed.ncbi.nlm.nih.gov

Evaluating the liver tumors using three-dimensional ultrasonography. A pictorial essay. [2016]

14. Greece pubmed.ncbi.nlm.nih.gov

Three-dimensional power Doppler ultrasonography for hepatocellular carcinoma: a comparison with angiography? [2006]