Recruiting NCT05705219

Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients

— Observational Liver Cancer, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: 3D-MPUS.
Who it may be relevant to: Registry conditions: Liver Cancer, Adult. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients With Abdominal and Pelvic Tumors Undergoing Therapy

Overview

Detailed description

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.

Interventions

Diagnostic test 3D-MPUS
Participants will receive approximately \< 20 minutes ultrasound scan to locate the lesion followed by acquisition of 3D-MPUS acquisition.

Primary outcome measures

Diagnostic yield of the 3D-MPUS data acquisition [Time frame: Baseline visit]

Eligibility criteria

Inclusion criteria

Participant has untreated liver metastases from colorectal low-grade adenocarcinoma (biopsy-proven and/or characteristic findings on CT, MRI, or FDG-PET) and has planned to undergo a new course of cancer therapy\*.
Participant is age >/=18 years.
Participant has at least one target lesion that measures ≥1cm in diameter (minimum size according to RECIST 1.1) with a maximum diameter of 14cm amenable to imaging with ultrasound
Participant is willing to comply with protocol requirements.
Participant has given written informed consent to participate in this study.

Any line of cancer therapy is allowed, including systemic and localized treatments, after any prior treatment. 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 upon progression on imaging after a treatment break. For combination treatments where patients start treatment with different drugs at different times, the start date of treatment is determined at the discretion of the investigators and can be the start date of the first drug or of the combination treatment. Repeat participation in the study is allowed, if patients are eligible again per their treatment plan.

Exclusion criteria

Participant has documented anaphylactic or other severe reaction to any ultrasound contrast media or polyethylene glycol (PEG).
Participant has any comorbid condition\*\* that, in the opinion of the treating provider or the Protocol Director, compromises the participant's ability to participate in the study.
Participant is pregnant (positive urine or serum beta-hCG) or lactating.
Presence of cardiac shunt or presence of pulmonary hypertension (contradiction for ultrasound contrast agent)
Renal insufficiency with a creatinine level >1.5mg/dl, per our institutional guidelines (contradiction for CT imaging).

Examples: any mental condition that compromises the ability to follow a consent discussion, or to make informed decisions (except if represented by a Legally Authorized Representative \[LAR\]); any condition that makes the participant not a good candidate to have ultrasound exams with contrast agent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

United States · 3 centers

Stanford University, School of Medicine — Palo Alto
University of California, San Diego — San Diego
Thomas Jefferson Hospital — Philadelphia

Identifiers

NCT: NCT05705219 · IRB-68310 · R01CA195443 · NCI-2024-03676

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗