Feasibility 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation

June 19, 2023 updated by: Stanford University

Feasibility of 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation

The purpose of this study 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objective:

The primary objectives of this prospective pilot study is to:

  1. determine the feasibility and reproducibility of 3D contrast enhanced ultrasound imaging in liver cancer patients undergoing Stereotactic Ablative Radiotherapy and
  2. 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

Interventional

Enrollment (Actual)

11

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

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University, School of Medicine

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

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

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: 3D Perfusion Ultrasound
undergo 3D ultrasound perfusion imaging with perflutren
Drug: perflutren lipid microspheres
Other Names:
  • Definity
Diagnostic test: 3D ultrasound

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

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Daniel T. Chang, 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 18, 2014

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimated)

April 23, 2015

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

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

No

Studies a U.S. FDA-regulated device product

Yes

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.

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