Recruiting

Decision Support Tool

Sponsor:

UCLA

Code:

NCT05705219

Conditions

Liver Cancer, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3D-MPUS

Study Details

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.

Conditions

Liver Cancer, Adult

Study ID

NCT05705219

Start date

Dec 4, 2023

Status verified date

Jan, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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\*.
2. Participant is age >/=18 years.
3. 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
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.
3. Participant is pregnant (positive urine or serum beta-hCG) or lactating.
4. Presence of cardiac shunt or presence of pulmonary hypertension (contradiction for ultrasound contrast agent)
5. 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.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

3-dimensional multi-parametric ultrasound imaging (3D-MPUS)

Participants will receive sulfur hexafluoride IV and undergo 3D-MPUS imaging over 20 minutes.

Interventions

3D-MPUS

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

Primary outcome measure

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

Central Contacts and Locations

Locations

Stanford University, School of Medicine

Recruiting

Palo Alto, California, United States, 94305

Contacts

Principal Investigator:

Aya Kamaya, MD

University of California, San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

Principal Investigator:

Ahmed El Kaffas, PhD

Thomas Jefferson Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Principal Investigator:

Andrej Lyshchik, MD, PhD

More Information

Sponsor

University of California, San Diego

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • Diagnostic Study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-01-26.