Pilot 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Liver Metastases
June 8, 2022 updated by: Stanford University
Pilot Technical Feasibility Study on 3D Contrast-enhanced Ultrasound Imaging and to Assess Whether Change in Ultrasound 3D Perfusion Pattern Can Predict Treatment Response
Patients are invited to participate in a research study of liver perfusion (how blood flows to the liver over time).
Researchers hope to learn whether perfusion characteristics of liver metastases may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment.
Patients were selected as a possible participant in this study because they are identified as having liver metastases
Study Overview
Status
Completed
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. The purpose of this study is to perform a pilot feasibility study on 3-dimensional (3D) ultrasound imaging of liver metastases and to evaluate whether perfusion characteristics (measurements of blood-flow) of hepatic metastases can predict tumor response to treatment in patients with liver metastases. The investigators long term goal is to assess whether early perfusion changes at 2 weeks after chemotherapy initiation can be used as a non-invasive early biomarker for treatment response assessment.
OUTLINE:
Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy, at 2 weeks, and at 2 months.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- Provides written Informed Consent and is willing to comply with protocol requirements.
- Has at least 1 focal lesion in liver or kidney
- Patient may be (i) in the process of receiving treatment (1 scan session), (ii) never treated (3 scan sessions) or (iii) changing treatment regimen/ type and/or receiving a new form of treatment and/or has been on a treatment break ('holiday')(3 scan session)
- Is at least18 years of age.
Exclusion Criteria
- Is determined by the Investigator that the subject is clinically unsuitable for the study.
- Known right to left cardiac shunt, bidirectional or transient.
- Hypersensitivity to perflutren.
- Hypersenstivity to the contrast agent Definity.
- Pregnant and lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic (3D contrast-enhanced ultrasound imaging)
Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy and at 2 weeks.
|
Ultrasound imaging procedure
Other Names:
Optical Tracking Device, manufactured by Atracsys LLC, Switzerland.
Electromagnetic Tracking Device, Ascension Technology Corporation, Milton, Vermont.
Perflutren lipid microsphere, IV 0.4 mL.
Used as standard contrast agent, not the subject of the study.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurements of blood flow, in terms of comparison of the perfusion parameters of the lesion as a predictor of tumor response to treatment and use as a biomarker for response to treatment
Time Frame: Baseline
|
Descriptive statistics will be presented for lesion size, by lesion type, and across lesion types.
Lesion shape, depth, vascularization, and border definition will also be categorized by dose and lesion type.
Based on the unenhanced ultrasound, the target lesion to liver echogenicity will be categorized by lesion type.
Based on the Definity®-enhanced ultrasound, the pattern of enhancement of the target lesion will be summarized by lesion type.
|
Baseline
|
|
Measurements of blood flow, in terms of comparison of the perfusion parameters of the lesion as a predictor of tumor response to treatment and use as a biomarker for response to treatment
Time Frame: 2 weeks after chemotherapy initiation
|
Descriptive statistics will be presented for lesion size, by lesion type, and across lesion types.
Lesion shape, depth, vascularization, and border definition will also be categorized by dose and lesion type.
Based on the unenhanced ultrasound, the target lesion to liver echogenicity will be categorized by lesion type.
Based on the Definity®-enhanced ultrasound, the pattern of enhancement of the target lesion will be summarized by lesion type.
|
2 weeks after chemotherapy initiation
|
|
Measurements of blood flow, in terms of comparison of the perfusion parameters of the lesion as a predictor of tumor response to treatment and use as a biomarker for response to treatment
Time Frame: 2 months post-treatment
|
Descriptive statistics will be presented for lesion size, by lesion type, and across lesion types.
Lesion shape, depth, vascularization, and border definition will also be categorized by dose and lesion type.
Based on the unenhanced ultrasound, the target lesion to liver echogenicity will be categorized by lesion type.
Based on the Definity®-enhanced ultrasound, the pattern of enhancement of the target lesion will be summarized by lesion type.
|
2 months post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aya Kamaya, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2012
Primary Completion (Actual)
August 31, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
June 26, 2012
First Submitted That Met QC Criteria
June 27, 2012
First Posted (Estimate)
June 29, 2012
Study Record Updates
Last Update Posted (Actual)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 8, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-24334
- NCI-2012-01008 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 1R01CA195443 (U.S. NIH Grant/Contract)
- HEP0043 (Other Identifier: OnCore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.