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

Primary Purpose

Liver Cancer, Liver Tumor, Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
perflutren lipid microspheres
3D ultrasound
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Cancer focused on measuring Liver cancer, Hepatocellular Carcinoma, Liver imaging, Stereotactic Ablative Radiotherapy, SABR

Eligibility Criteria

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

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

Sites / Locations

  • Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3D Perfusion Ultrasound

Arm Description

undergo 3D ultrasound perfusion imaging with perflutren

Outcomes

Primary Outcome Measures

Changes in Blood Perfusion (Blood Volume)
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.
Changes in Blood Perfusion (Mean Flow Velocity)
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.
Changes in Blood Perfusion (Relative Blood Flow)
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.

Secondary Outcome Measures

Full Information

First Posted
April 16, 2015
Last Updated
June 19, 2023
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02424955
Brief Title
Feasibility 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation
Official Title
Feasibility of 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2014 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Liver Tumor, Hepatocellular Carcinoma, Liver Carcinoma
Keywords
Liver cancer, Hepatocellular Carcinoma, Liver imaging, Stereotactic Ablative Radiotherapy, SABR

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
3D Perfusion Ultrasound
Arm Type
Experimental
Arm Description
undergo 3D ultrasound perfusion imaging with perflutren
Intervention Type
Drug
Intervention Name(s)
perflutren lipid microspheres
Other Intervention Name(s)
Definity
Intervention Type
Diagnostic Test
Intervention Name(s)
3D ultrasound
Primary Outcome Measure Information:
Title
Changes in Blood Perfusion (Blood Volume)
Description
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.
Time Frame
Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
Title
Changes in Blood Perfusion (Mean Flow Velocity)
Description
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.
Time Frame
Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
Title
Changes in Blood Perfusion (Relative Blood Flow)
Description
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.
Time Frame
Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel T. Chang
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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

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