Pilot 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Liver Metastases
Pilot Technical Feasibility Study on 3D Contrast-enhanced Ultrasound Imaging and to Assess Whether Change in Ultrasound 3D Perfusion Pattern Can Predict Treatment Response
4 other identifiers
interventional
34
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2012
CompletedFirst Posted
Study publicly available on registry
June 29, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedJune 10, 2022
June 1, 2022
7.8 years
June 26, 2012
June 8, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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
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
Study Arms (1)
Diagnostic (3D contrast-enhanced ultrasound imaging)
EXPERIMENTALPatients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy and at 2 weeks.
Interventions
Ultrasound imaging procedure
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Cancer Institute (NCI)collaborator
- Philips Healthcarecollaborator
Study Sites (1)
Stanford University
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aya Kamaya
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2012
First Posted
June 29, 2012
Study Start
November 1, 2012
Primary Completion
August 31, 2020
Study Completion
September 30, 2020
Last Updated
June 10, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share