Development of 3DMPUS as a Decision Support Tool for Patients With Liver Tumors Undergoing Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Development of 3DMPUS as a Decision Support Tool for Patients With Liver Tumors Undergoing Therapy

Conditions
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Liver Cancer, Adult

Intervention / Treatment
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* Diagnostic Test: 3D-MPUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participant is about to undergo a new course of therapy for primary or metastatic liver cancer. The participant is age > 18 years. Participant has at least one target lesion (≥1cm and <14cm) The participant is willing to comply with protocol requirements. The participant has the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Participant has documented anaphylactic or other severe reactions to any ultrasound or CT contrast media. Participant has documented severe Hypersensitivity to macrogol/ polyethylene glycol (PEG). Participant has documented the presence of a cardiac shunt or pulmonary hypertension (pulmonary artery pressure >90 mmHg). Participant has documented renal insufficiency with a creatinine level of >1.5mg/dl. Participant has documented uncontrolled systemic hypertension. Participant has documented concomitant diseases like acute endocarditis, prosthetic valve, hyperactive coagulation states and/ or recent thromboembolism, and sepsis Participant is pregnant (positive urine or serum beta-hCG) or lactating.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-dimensional multi-parametric ultrasound imaging (3D-MPUS)<br>Participants will receive sulfur hexafluoride IV and undergo 3D-MPUS imaging over 20 minutes. | Diagnostic Test: 3D-MPUS<br>* Participants will receive approximately < 20 minutes ultrasound scan to locate the lesion followed by acquisition of 3D-MPUS acquisition.<br>* Other names: 3-dimensional multi-parametric ultrasound imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of the 3D-MPUS data acquisition | Diagnostic yield will be the percentage of non-missing measurements (per reader, per measurement) Participants with successful measurements of the following parameters (following administration of a radiotracer). volume peak enhancement (PE) area-under-the-curve (AUC) time-to-peak (TP) mean-transit-time (MTT) mid-band fit (MBF) spectral slope (SS) spectral intercept (SI) Readers include Principal Investigator and technician. | Baseline visit (average approximately to 45 minutes to perform scan) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-reader agreement for 3D-MPUS measurements at first scan | Investigators will test for a difference between responders and non-responders, using a Wilcoxon rank-sum test. Readers include Principal Investigator and technician. | Baseline visit (average approximately to 45 minutes to assess scan) | 
| Relationship between baseline and one-month 3D-MPUS measurements and treatment response after three-months | Investigators will perform univariable and multivariable logistic regressions of treatment response at three months on percent change in measurements between baseline and one-month post treatment. | Baseline and 3 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic Study