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

Liver Cancer, Adult Clinical Trial

— 3DMPUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705219
• Other study ID #: IRB-68310
• Secondary ID: R01CA195443NCI-2
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: David Marcellus, BS
• Phone: (650) 723-4547
• Email: dmarcel2[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer, Adult

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California
United States	Thomas Jefferson Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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.	Baseline visit (average approximately to 45 minutes to perform scan)
Secondary	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)
Secondary	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