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

Not Applicable

Recruiting

• Conditions: Liver Cancer, Adult
• Interventions: Diagnostic Test: 3D-MPUS

• Registration Number: NCT05705219
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-30
• Study Start: 2023-12-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-20
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Participant is planned to undergo a new course of cancer therapy*.

2. Participant is age >/=18 years.

3. Participant has at least one target lesion (≥1cm and <14cm) amenable to imaging with ultrasound

4. Participant is willing to comply with protocol requirements.

5. 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

1. Participant has documented anaphylactic or other severe reaction to any ultrasound contrast media or polyethylene glycol (PEG).

2. 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.

   • 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3-dimensional multi-parametric ultrasound imaging (3D-MPUS)	3D-MPUS	Participants will receive sulfur hexafluoride IV and undergo 3D-MPUS imaging over 20 minutes.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield of the 3D-MPUS data acquisition	Baseline visit (average approximately to 45 minutes to perform scan)	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.

Secondary Outcome Measures

Name	Time	Method
Inter-reader agreement for 3D-MPUS measurements at first scan	Baseline visit (average approximately to 45 minutes to assess scan)	Investigators will test for a difference between responders and non-responders, using a Wilcoxon rank-sum test.; Readers include Principal Investigator and technician.
Relationship between baseline and one-month 3D-MPUS measurements and treatment response after three-months	Baseline and 3 months post treatment	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.

Trial Locations

Locations (2)

Stanford University, School of Medicine; 🇺🇸 Palo Alto, California, United States

Thomas Jefferson Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States