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3D Multi-Parametric Ultrasound for Early Assessment of Treatment Response among Patients Undergoing Therapy for Liver Cancer
Trial Status: active
This clinical trial evaluates the usefulness of 3-dimensional (3D) multi-parametric ultrasound (MPUS) for early treatment response assessment in patients receiving treatment for liver cancer. There is a significant need to determine which cancer patients will respond to treatment before or shortly after initiation of therapy. In organs that are well visualized with ultrasound, such as the liver, repeated imaging with dynamic contrast-enhanced ultrasound is practical and could complement other advanced imaging solutions for early treatment response assessment. 3D MPUS (a type of dynamic contrast-enhanced ultrasound) may be able to guide therapy administration and improve clinical outcomes of therapy by measuring patient response to treatment earlier.
Inclusion Criteria
Participant is about to undergo a new course of therapy (they receive 1st – 3rd line treatment for primary or metastatic liver cancer.
Participant is age >/= 18 years.
Participant has at least one target lesion (≥ 1cm and < 14cm).
Participant is willing to comply with protocol requirements.
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 reaction to any ultrasound or CT contrast media.
Participant has documented severe hypersensitivity to macrogol/ polyethylene glycol (PEG).
Participant has documented presence of a cardiac shunt or presence of 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 acute endocarditis with prosthetic valve placement, hyperactive coagulation states and/ or recent thromboembolism, and sepsis.
Participant is pregnant (positive urine or serum beta-human chorionic gonadotropin [hCG]) or lactating.
Additional locations may be listed on ClinicalTrials.gov for NCT05705219.
I. Assess diagnostic yield of 3D-MPUS data acquisition.
SECONDARY OBJECTIVES:
I. Assess inter-reader agreement for 3D MPUS measurements.
II. Assess the relationship between 3D MPUS measurements and treatment response at three months post-treatment.
OUTLINE:
Patients receive SonoVue intravenously (IV) and undergo 3D MPUS at baseline (prior to starting standard of care [SOC] treatment), approximately 1-3 weeks after start of SOC treatment, and again within 3 weeks of the time of their final SOC imaging with computed tomography (CT), magnetic resonance imaging (MRI) and/or positron emission tomography (PET)/CT for response evaluation (about 60-90 days after SOC treatment start). Patients may also optionally receive SonoVue IV and undergo 3D MPUS approximately 2-6 weeks after SOC treatment start and 4-10 weeks after SOC treatment start. Patients also undergo CT, MRI, and/or x-ray at baseline and on study.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationStanford Cancer Institute Palo Alto
