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RecruitingNCT057052193DMPUSUpdated Jan 26, 2026

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

An observational study in Liver Cancer, Adult, sponsored by University of California, San Diego. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.

Sponsored by University of California, San Diego · Observational

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Liver Cancer, Adult

Keywords

  • Diagnostic Study
03

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's planned enrollment of 80 is below the median of 200 across 754 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  1. The participant is about to undergo a new course of therapy for primary or metastatic cancer in the abdominal or pelvic region.
  2. The participant is age > 18 years.
  3. Participant has at least one target lesion (≥1cm and \<14cm)
  4. The participant is willing to comply with protocol requirements.
  5. The participant has the ability to understand and the willingness to sign a written informed consent document.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

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

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

    Diagnostic Test: 3D-MPUS

Interventions

  • Diagnostic test3D-MPUS

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

    Also known as: 3-dimensional multi-parametric ultrasound imaging

06

What researchers measure

Primary outcomes

  1. Diagnostic yield of the 3D-MPUS data acquisition

    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 contrast agent). * peak enhancement (PE)

    Time frame: Baseline visit

07

Study locations

3 of 3 sites recruiting
  • Stanford University, School of Medicine
    Palo Alto, California 94305, United States
    • David Marcellus, BS · Contact · dmarcel2@stanford.edu · (650) 723-4547
    • Aya Kamaya, MD · Principal investigator
    Recruiting
  • University of California, San Diego
    San Diego, California 92037, United States
    Recruiting
  • Thomas Jefferson Hospital
    Philadelphia, Pennsylvania 19107, United States
    • Andrej Lyshchik, MD, PhD · Principal investigator
    • John Eisenbrey, PhD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05705219
Lead sponsor
University of California, San Diego
Collaborators
National Cancer Institute (NCI)
Responsible party
Ahmed El Kaffas (Associate Professor, University of California, San Diego) — Principal investigator
First posted
Jan 30, 2023
Start date
Dec 4, 2023
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jan 26, 2026

Study contacts

David Marcellus, BS
Contact
dmarcel2@stanford.edu
(650) 723-4547
Suzanna Lee
Contact
suzanna@health.ucsd.edu
+1 (858)-534-1475
Ahmed El Kaffas, PhD
principal investigator · University of California, San Diego
Aya Kamaya, MD
study director · Stanford University
Andrej Lyshchik, MD, PhD
study director · Thomas Jefferson University
Aman Khurana, MD
study director · University of California, San Diego
Yuko Kono, MD, PhD, FAIUM, FAASLD
study director · University of California, San Diego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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