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Pilot 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Liver Metastases

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ClinicalTrials.gov Identifier: NCT01631318
Recruitment Status : Suspended (Scientific)
First Posted : June 29, 2012
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Philips Healthcare
Information provided by (Responsible Party):
Stanford University

Study Description
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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

Condition or disease Intervention/treatment Phase
Liver Metastases Colon Cancer Procedure: dynamic contrast-enhanced ultrasound imaging Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. The purpose of this study is to perform a pilot feasibility study on 3-dimensional (3D) ultrasound imaging of liver metastases and to evaluate whether perfusion characteristics (measurements of blood-flow) of hepatic metastases can predict tumor response to treatment in patients with liver metastases. The investigators long term goal is to assess whether early perfusion changes at 2 weeks after chemotherapy initiation can be used as a non-invasive early biomarker for treatment response assessment.

OUTLINE:

Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy, at 2 weeks, and at 2 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Technical Feasibility Study on 3D Contrast-enhanced Ultrasound Imaging and to Assess Whether Change in Ultrasound 3D Perfusion Pattern Can Predict Treatment Response
Study Start Date : November 2012
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Diagnostic (3D contrast-enhanced ultrasound imaging)
Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy and at 2 weeks.
 Procedure: dynamic contrast-enhanced ultrasound imaging
Undergo 3D contrast enhanced ultrasound imaging
Other Name: DCE-USI


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Baseline ]
    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. 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 [ Time Frame: 2 weeks after chemotherapy initiation ]
    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.

  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 [ Time Frame: 2 months post-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.


Eligibility Criteria
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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

  • 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.

Exclusion Criteria

  • 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
Contacts and Locations
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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): NCT01631318


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Philips Healthcare
Investigators
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Principal Investigator: Aya Kamaya Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01631318    
Other Study ID Numbers: HEP0043
NCI-2012-01008 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1R01CA195443 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes