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

NCT05705219 | Recruiting FDA Device

• 3 other identifiers: IRB-68310R01CA195443NCI-2024-03676
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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

Keywords

Diagnostic Study

Outcome Measures

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)

  Baseline visit

Study Arms (1)

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

3D-MPUS DIAGNOSTIC_TEST

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Stanford University, School of Medicine

Palo Alto, California, 94305, United States

RECRUITING

University of California, San Diego

San Diego, California, 92037, United States

RECRUITING

Thomas Jefferson Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Disease

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed El Kaffas, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Central Study Contacts

David Marcellus, BS

CONTACT

(650) 723-4547; dmarcel2@stanford.edu

Suzanna Lee

CONTACT

+1 (858)-534-1475; suzanna@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 30, 2023
• Study Start: December 4, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)