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

NCT ID: NCT05705219

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2028-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

3D-MPUS

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

3D-MPUS

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

3-dimensional multi-parametric ultrasound imaging

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Ahmed El Kaffas

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aya Kamaya, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Andrej Lyshchik, MD, PhD

Role: STUDY_DIRECTOR

Thomas Jefferson University

Aman Khurana, MD

Role: STUDY_DIRECTOR

University of California, San Diego

Yuko Kono, MD, PhD, FAIUM, FAASLD

Role: STUDY_DIRECTOR

University of California, San Diego

Locations

Stanford University, School of Medicine

Palo Alto, California, United States

University of California, San Diego

San Diego, California, United States

Thomas Jefferson Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R01CA195443

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2024-03676

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-68310

Identifier Type: -

Identifier Source: org_study_id