Liver Cancer, Adult3DMPUSNCT05705219
Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients
An observational study of Liver Cancer, Adult, run by University of California, San Diego at 3 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Adult
- What is being tested?
- 3D-MPUS
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Dec 2023to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Stanford University, School of Medicine
Palo Alto, California, 94305
David Marcellus, BS, (650) 723-4547, dmarcel2@stanford.edu
Aya Kamaya, MD
- Recruiting
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, 19107
Andrej Lyshchik, MD, PhD
John Eisenbrey, PhD
- Recruiting
University of California, San Diego
San Diego, California, 92037
Suzanna Lee, +1(858)-534-1475, suzanna@health.ucsd.edu
Allison Law, awlaw@health.ucsd.edu
About this study
Official title: Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients With Abdominal and Pelvic Tumors Undergoing Therapy
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.
- Conditions
- Liver Cancer, Adult
- Being tested
- 3D-MPUS
- Keywords
- Diagnostic Study
- Medical subject headings
- Carcinoma, Hepatocellular, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-MPUSDiagnostic test
Also called 3-dimensional multi-parametric ultrasound imaging
Participants will receive approximately < 20 minutes ultrasound scan to locate the lesion followed by acquisition of 3D-MPUS acquisition.
| Study group | Role | What they receive |
|---|---|---|
| 3-dimensional multi-parametric ultrasound imaging (3D-MPUS) | Participants will receive sulfur hexafluoride IV and undergo 3D-MPUS imaging over 20 minutes. Receives: Diagnostic Test: 3D-MPUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start4 Dec 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer, AdultStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ahmed El Kaffas, University of California, San Diego
- Investigators
- Ahmed El Kaffas, PhD, Principal investigator, University of California, San DiegoAya Kamaya, MD, Study director, Stanford UniversityAndrej Lyshchik, MD, PhD, Study director, Thomas Jefferson UniversityAman Khurana, MD, Study director, University of California, San DiegoYuko Kono, MD, PhD, FAIUM, FAASLD, Study director, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705219
- Sponsor's protocol ID
- IRB-68310
- Other IDs
- R01CA195443, NCI-2024-03676
- Acronym
- 3DMPUS
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2023
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients With Abdominal and Pelvic Tumors Undergoing Therapy
- ClinicalTrials.gov ID
- NCT05705219
- Acronym / sponsor ID
- 3DMPUS / IRB-68310
- Conditions
- Liver Cancer, Adult
- Keywords
- Diagnostic Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3-dimensional multi-parametric ultrasound imaging (3D-MPUS) | – | Diagnostic Test: 3D-MPUSParticipants will receive sulfur hexafluoride IV and undergo 3D-MPUS imaging over 20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-MPUSAlso: 3-dimensional multi-parametric ultrasound imagingParticipants will receive approximately < 20 minutes ultrasound scan to locate the lesion followed by acquisition of 3D-MPUS acquisition. | Diagnostic test | 3-dimensional multi-parametric ultrasound imaging (3D-MPUS) |
Primary outcome
Diagnostic yield of the 3D-MPUS data acquisition
Time frame: Baseline visit
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, Adult, run by University of California, San Diego at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Marcellus, BS ((650) 723-4547, dmarcel2@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield of the 3D-MPUS data acquisition (time frame: Baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.