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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer, Adult
• Intervention / Treatment: Diagnostic test: 3D-MPUS

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 Type: Observational
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Marcellus, BS; Phone Number: (650) 723-4547; Email: dmarcel2@stanford.edu
• Study Contact Backup: Name: Suzanna Lee; Phone Number: +1 (858)-534-1475; Email: suzanna@health.ucsd.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Recruiting
      • Stanford University, School of Medicine
      • Contact: David Marcellus, BS; Phone Number: (650) 723-4547; Email: dmarcel2@stanford.edu
      • Principal Investigator: Aya Kamaya, MD
    • San Diego, California, United States, 92037
      • Recruiting
      • University of California, San Diego
      • Principal Investigator: Ahmed El Kaffas, PhD
      • Contact: Suzanna Lee; Phone Number: +1(858)-534-1475; Email: suzanna@health.ucsd.edu
      • Contact: Allison Law; Email: awlaw@health.ucsd.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson Hospital
      • Principal Investigator: Andrej Lyshchik, MD, PhD
      • Sub-Investigator: John Eisenbrey, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Participants will receive approximately < 20 minutes ultrasound scan to locate the lesion followed by acquisition of 3D-MPUS acquisition.; Other Names: 3-dimensional multi-parametric ultrasound imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline visit

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Director: Aya Kamaya, MD, Stanford University; Study Director: Andrej Lyshchik, MD, PhD, Thomas Jefferson University; Study Director: Aman Khurana, MD, University of California, San Diego; Study Director: Yuko Kono, MD, PhD, FAIUM, FAASLD, University of California, San Diego; Principal Investigator: Ahmed El Kaffas, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Diagnostic Study
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Pathological Conditions, Signs and Symptoms; Carcinoma, Hepatocellular; Disease
• Other Study ID Numbers: IRB-68310; R01CA195443 (U.S. NIH Grant/Contract); NCI-2024-03676 (Other Identifier: CTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No