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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02424955
Recruitment Status : Recruiting
First Posted : April 23, 2015
Last Update Posted : June 13, 2022
Sponsor:
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment Phase
Liver Cancer Liver Tumor Hepatocellular Carcinoma Liver Carcinoma Drug: perflutren lipid microspheres Diagnostic Test: 3D ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility of 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation
Actual Study Start Date : November 18, 2014
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
Drug Information available for: Perflutren

Arm Intervention/treatment
Experimental: 3D Perfusion Ultrasound
undergo 3D ultrasound perfusion imaging with perflutren
Drug: perflutren lipid microspheres
Other Name: Definity

Diagnostic Test: 3D ultrasound



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424955


Contacts
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Contact: Jen-Yeu Wang 650-723-3110 jenyeu@stanford.edu

Locations
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United States, California
Stanford University, School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Jen-Yeu Wang    650-723-3110    jenyeu@stanford.edu   
Principal Investigator: Dimitre Hristov         
Principal Investigator: Albert Koong         
Sub-Investigator: Aya Kamaya         
Sub-Investigator: Juergen Willmann         
Principal Investigator: Daniel Chang         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Daniel T. Chang Stanford University
  Study Documents (Full-Text)

Documents provided by Stanford University:
Informed Consent Form  [PDF] August 11, 2021

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02424955    
Other Study ID Numbers: IRB-30071
IRB-30071 ( Other Identifier: Stanford IRB )
HEP0048 ( Other Identifier: OnCore )
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: June 13, 2022
Last Verified: June 2022

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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
Keywords provided by Stanford University:
Liver cancer
Hepatocellular Carcinoma
Liver imaging
Stereotactic Ablative Radiotherapy
SABR
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases