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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Stanford University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01631318
First received: June 26, 2012
Last updated: May 18, 2016
Last verified: May 2016
  Purpose
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 Intervention
Liver Metastases
Colon Cancer
Procedure: dynamic contrast-enhanced ultrasound imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: November 2012
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631318

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Juergen Willmann    650-725-1812    willmann@stanford.edu   
Principal Investigator: Juergen K. Willmann         
Sub-Investigator: George A. Fisher         
Sub-Investigator: Sanjiv S. Gambhir         
Sub-Investigator: Amelie Lutz         
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Juergen Willmann Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01631318     History of Changes
Other Study ID Numbers: HEP0043  NCI-2012-01008 
Study First Received: June 26, 2012
Last Updated: May 18, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on December 06, 2016