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3D Multi-Parametric Ultrasound for Early Assessment of Treatment Response among Patients Undergoing Therapy for Abdominal or Pelvic Tumors
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 tumors in the abdomen or pelvis. 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 planned to undergo a new course of cancer therapy for primary or metastatic abdominal or pelvic cancer
* Any line of cancer therapy is allowed, including both standard of care or investigational treatments and drugs, whether systemic or localized, following any prior treatments. Participants currently on investigational cancer treatments, investigational drugs, or enrolled in other clinical trials are eligible, provided they meet all other study criteria and the trial protocol allows concurrent enrollment in other research studies.
* For systemic combination treatments, prior treatment with either drug is allowed at the discretion of the investigators; including rechallenges with the same drug combination (for example, after disease progression on imaging following a treatment break). For combination treatments where patients begin treatment with different drugs at different times, the start date of treatment is determined at the discretion of the investigators and can either be the start date of the first drug or of the combination treatment. Repeat participation in the study is allowed if patients meet eligibility criteria according to their treatment plan.
Participant is age >/= 18 years.
Participant has at least one target lesion (≥ 1 cm and < 14 cm) amenable to imaging with ultrasound
Participant is willing to comply with protocol requirements.
Participant has given written informed consent to participate in this study
Exclusion Criteria
Participant has a history of severe or anaphylactic reactions to any ultrasound contrast media.
Participant has a history of hypersensitivity reactions to sulfur hexafluoride or any of its components, such as polyethylene glycol (PEG).
Participant has any comorbidities that, in the opinion of the treating provider or the principal investigator, would compromise the participant’s ability to participate in the study.
* Examples include any mental condition that compromises the participant’s ability to understand the consent process or make informed decisions (unless represented by a legally authorized representative), significant concurrent diseases, or any condition that makes the participant unsuitable for ultrasound procedures involving a contrast agent.
Study sponsor and potential other locations can be found 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.
EXPLORATORY OBJECTIVES:
I. To utilize molecular genotyping to characterize patients by clinically relevant disease classifications for precision medicine and treatment response.
II. To investigate prognostic and predictive biomarkers of response and resistance to therapy.
III. To utilize biomarkers and computational spatial imaging data from ultrasound scans to evaluate whether new information could potentially help providers better manage patient treatment response.
OUTLINE:
Patients receive SonoVue intravenously (IV) and undergo 3D MPUS at baseline (within 1 month [30 days] prior to starting standard of care [SOC] treatment) and at approximately 1-4 weeks after start of SOC or investigational treatment. In addition, patients receive SonoVue IV and undergo 3D MPUS optionally at either 1) approximately 2-6 weeks after start of SOC or investigational treatment, 2) 4-10 weeks after start of SOC or investigational treatment, or 3) approximately 3 weeks before or after the first follow-up SOC imaging used for treatment evaluation (typically 8-16 weeks after the start of treatment) and at least one week after any prior visit. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and/or x-ray throughout the study.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUC San Diego Moores Cancer Center
