- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02424955
Feasibility 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation
Feasibility of 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation
Study Overview
Status
Intervention / Treatment
Detailed Description
Primary Objective:
The primary objectives of this prospective pilot study is to:
- determine the feasibility and reproducibility of 3D contrast enhanced ultrasound imaging in liver cancer patients undergoing Stereotactic Ablative Radiotherapy and
- evaluate whether there are treatment induced early changes in imaging metrics derived from 3D contrast enhanced ultrasound. This study will provide valuable insight as to the potential of baseline and/or early post-treatment 3D ultrasound perfusion characteristics (measurements of blood-flow) of primary and metastatic liver tumors to predict tumor response to Stereotactic Ablative Radiotherapy. The investigators' underlying goal is to assess whether early perfusion changes at 1-7 days after SABR initiation can be used as a non-invasive early biomarker for treatment response assessment.
Secondary Objectives:
Evaluate the feasibility of contrast-enhanced ultrasound-to-CT fusion by assisting three-dimensional (3D) perfusion ultrasound (US) imaging with optical and electromagnetic tracking of the ultrasound probe on patients with liver cancer that will undergo CT for treatment planning and/or response evaluation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jen-Yeu Wang
- Phone Number: 650-723-3110
- Email: jenyeu@stanford.edu
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University, School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ability to understand and willingness to sign the written informed consent document
- Patient with primary liver tumor or metastasis scheduled for Stereotactic Ablative Radiotherapy (SABR)
- Patient is at least 18 years of age. No gender/race-ethnic restrictions.
- Performance status (ECOG) between 0-3
- History and Physical done within 4 weeks of enrollment.
Exclusion Criteria:
- Patient has previously been enrolled in and completed this study.
- Known right to left cardiac shunt, bidirectional or transient.
- Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
- History of hypersensitivity to the contrast agent perflutren
- History of pulmonary hypertension
- Patients who are pregnant or are trying to become pregnant
Study Plan
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: 3D Perfusion Ultrasound
undergo 3D ultrasound perfusion imaging with perflutren
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Blood Perfusion (Blood Volume)
Time Frame: Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
|
The purpose of this pilot project is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.
|
Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
|
Changes in Blood Perfusion (Mean Flow Velocity)
Time Frame: Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
|
The purpose of this pilot project is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.
|
Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
|
Changes in Blood Perfusion (Relative Blood Flow)
Time Frame: Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
|
The purpose of this pilot project is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.
|
Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel T. Chang, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-30071 (Other Identifier: Stanford IRB)
- HEP0048 (Other Identifier: OnCore)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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