Development of 3DMPUS as a Decision Support Tool for Patients With Liver Tumors Undergoing Therapy

• Sponsor: Stanford University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05705219
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 80
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 58
• Patients Per Site: 40
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cancer, Adult	Diagnostic Test: 3D-MPUS	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Development of 3DMPUS as a Decision Support Tool for Patients With Liver Tumors Undergoing Therapy
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3-dimensional multi-parametric ultrasound imaging (3D-MPUS) Patients receive sulfur hexafluoride IV and undergo 3D-MPUS imaging over 20 minutes.	Diagnostic Test: 3D-MPUS; Subjects 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

Outcome Measures

Primary Outcome Measures

1. Diagnostic yield of the 3D-MPUS data acquisition [Baseline visit (average approximately to 45 minutes to perform scan)]

   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 radiotracer). volume peak enhancement (PE) area-under-the-curve (AUC) time-to-peak (TP) mean-transit-time (MTT) mid-band fit (MBF) spectral slope (SS) spectral intercept (SI) Readers include Principal Investigator and technician.

Secondary Outcome Measures

1. Inter-reader agreement for 3D-MPUS measurements at first scan [Baseline visit (average approximately to 45 minutes to assess scan)]

   We will test for a difference between responders and non-responders, using a Wilcoxon rank-sum test. Readers include Principal Investigator and technician.

2. Relationship between baseline and one-month 3D-MPUS measurements and treatment response after three-months [Baseline and 3 months post treatment]

   We 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. The participant is about to undergo a new course of therapy for primary or metastatic liver cancer.

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.

Exclusion Criteria:

1. Participant has documented anaphylactic or other severe reactions to any ultrasound or CT contrast media.

2. Participant has documented severe Hypersensitivity to macrogol/ polyethylene glycol (PEG).

3. Participant has documented the presence of a cardiac shunt or pulmonary hypertension (pulmonary artery pressure >90 mmHg).

4. Participant has documented renal insufficiency with a creatinine level of >1.5mg/dl.

5. Participant has documented uncontrolled systemic hypertension.

6. Participant has documented concomitant diseases like acute endocarditis, prosthetic valve, hyperactive coagulation states and/ or recent thromboembolism, and sepsis

7. Participant is pregnant (positive urine or serum beta-hCG) or lactating.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University, School of Medicine	Palo Alto	California	United States	94305
2	Thomas Jefferson Hospital	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Stanford University
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Ahmed El Kaffas, PhD, Stanford University
• Study Director: Aya Kamaya, MD, Stanford University
• Study Director: Andrej Lyshchik, MD, PhD, Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Nagy El Kaffas, Clinical Instructor, Stanford University
• ClinicalTrials.gov Identifier: NCT05705219
• Other Study ID Numbers: IRB-68310; R01CA195443
• First Posted: Jan 30, 2023
• Last Update Posted: Jan 30, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Ahmed Nagy El Kaffas, Clinical Instructor, Stanford University: Diagnostic Study
• Additional relevant MeSH terms: Carcinoma, Hepatocellular

Study Results

No Results Posted as of Jan 30, 2023