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

Primary Purpose

Liver Cancer, Adult

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D-MPUS
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Cancer, Adult focused on measuring Diagnostic Study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The participant is about to undergo a new course of therapy for primary or metastatic liver cancer. The participant is age > 18 years. Participant has at least one target lesion (≥1cm and <14cm) The participant is willing to comply with protocol requirements. The participant has the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Participant has documented anaphylactic or other severe reactions to any ultrasound or CT contrast media. Participant has documented severe Hypersensitivity to macrogol/ polyethylene glycol (PEG). Participant has documented the presence of a cardiac shunt or pulmonary hypertension (pulmonary artery pressure >90 mmHg). Participant has documented renal insufficiency with a creatinine level of >1.5mg/dl. Participant has documented uncontrolled systemic hypertension. Participant has documented concomitant diseases like acute endocarditis, prosthetic valve, hyperactive coagulation states and/ or recent thromboembolism, and sepsis Participant is pregnant (positive urine or serum beta-hCG) or lactating.

Sites / Locations

  • Stanford University, School of Medicine
  • Thomas Jefferson Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Inter-reader agreement for 3D-MPUS measurements at first scan
We will test for a difference between responders and non-responders, using a Wilcoxon rank-sum test. Readers include Principal Investigator and technician.
Relationship between baseline and one-month 3D-MPUS measurements and treatment response after three-months
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.

Full Information

First Posted
January 18, 2023
Last Updated
January 18, 2023
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05705219
Brief Title
Development of 3DMPUS as a Decision Support Tool for Patients With Liver Tumors Undergoing Therapy
Acronym
3DMPUS
Official Title
Development of 3DMPUS as a Decision Support Tool for Patients With Liver Tumors Undergoing Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Adult
Keywords
Diagnostic Study

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3-dimensional multi-parametric ultrasound imaging (3D-MPUS)
Arm Type
Experimental
Arm Description
Patients receive sulfur hexafluoride IV and undergo 3D-MPUS imaging over 20 minutes.
Intervention Type
Diagnostic Test
Intervention Name(s)
3D-MPUS
Other Intervention Name(s)
3-dimensional multi-parametric ultrasound imaging
Intervention Description
Subjects will receive approximately < 20 minutes ultrasound scan to locate the lesion followed by acquisition of 3D-MPUS acquisition.
Primary Outcome Measure Information:
Title
Diagnostic yield of the 3D-MPUS data acquisition
Description
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.
Time Frame
Baseline visit (average approximately to 45 minutes to perform scan)
Secondary Outcome Measure Information:
Title
Inter-reader agreement for 3D-MPUS measurements at first scan
Description
We will test for a difference between responders and non-responders, using a Wilcoxon rank-sum test. Readers include Principal Investigator and technician.
Time Frame
Baseline visit (average approximately to 45 minutes to assess scan)
Title
Relationship between baseline and one-month 3D-MPUS measurements and treatment response after three-months
Description
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.
Time Frame
Baseline and 3 months post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participant is about to undergo a new course of therapy for primary or metastatic liver cancer. The participant is age > 18 years. Participant has at least one target lesion (≥1cm and <14cm) The participant is willing to comply with protocol requirements. The participant has the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Participant has documented anaphylactic or other severe reactions to any ultrasound or CT contrast media. Participant has documented severe Hypersensitivity to macrogol/ polyethylene glycol (PEG). Participant has documented the presence of a cardiac shunt or pulmonary hypertension (pulmonary artery pressure >90 mmHg). Participant has documented renal insufficiency with a creatinine level of >1.5mg/dl. Participant has documented uncontrolled systemic hypertension. Participant has documented concomitant diseases like acute endocarditis, prosthetic valve, hyperactive coagulation states and/ or recent thromboembolism, and sepsis Participant is pregnant (positive urine or serum beta-hCG) or lactating.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Marcellus, BS
Phone
(650) 723-4547
Email
dmarcel2@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed El Kaffas, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aya Kamaya, MD
Organizational Affiliation
Stanford University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrej Lyshchik, MD, PhD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Marcellus, BS
Phone
650-723-4547
Email
dmarcel2@stanford.edu
First Name & Middle Initial & Last Name & Degree
Ahmed El Kaffas, PhD
First Name & Middle Initial & Last Name & Degree
Aya Kamaya, MD
Facility Name
Thomas Jefferson Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrej Lyshchik, MD, PhD
First Name & Middle Initial & Last Name & Degree
John Eisenbrey, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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