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Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

Primary Purpose

Liver Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
perflutren lipid microspheres
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Neoplasms focused on measuring liver cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with primary hepatocellular carcinoma (HCC) or secondary (metastatic) carcinoma of the liver who have been referred for ultrasound-guided radiofrequency ablation (RFA) treatment
  • Recent (within 90 days) CT or MRI scan with report of one or more tumors ≤ 1.5 cm in diameter
  • Patient is stable and is to be managed conservatively (i.e. non-surgically)
  • 18 years of age or older
  • Ability and willingness to provide written informed consent

Exclusion Criteria:

  • Known or suspected cardiac shunt(s)
  • Known sensitivity to octafluoropropane
  • Pregnant or breastfeeding

Sites / Locations

  • UC Davis Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Contrast sonography

Arm Description

Contrast-enhanced sonography perflutren lipid microspheres

Outcomes

Primary Outcome Measures

Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography
After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images. The images pre-contrast and post contrast are compared visually. One tumor per participant was analyzed.

Secondary Outcome Measures

Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth
Visual estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography using prior assessment or pathology for tumor type

Full Information

First Posted
December 21, 2007
Last Updated
July 10, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT00584402
Brief Title
Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
Official Title
Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy of the Definity (perflutren lipid microsphere Injectable Suspension) ultrasound contrast agent in identifying small tumors (hepatomas & metastases) within the liver. Primary objective: To estimate the increase in conspicuity of small intrahepatic tumors with contrast-enhanced sonography Secondary Objectives: To estimate the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography
Detailed Description
An estimated 75 patients (age 18 years of age or older) will be enrolled from the population of patients who present for ultrasound-guided radiofrequency ablation (RFA) of CT or MRI-confirmed multiple primary hepatocellular carcinoma (HCC) or metastatic carcinoma, with at least one of the tumors being ≤ 1.5 cm in diameter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms
Keywords
liver cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Contrast sonography
Arm Type
Experimental
Arm Description
Contrast-enhanced sonography perflutren lipid microspheres
Intervention Type
Drug
Intervention Name(s)
perflutren lipid microspheres
Other Intervention Name(s)
Definity
Intervention Description
perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
Primary Outcome Measure Information:
Title
Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography
Description
After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images. The images pre-contrast and post contrast are compared visually. One tumor per participant was analyzed.
Time Frame
15 min
Secondary Outcome Measure Information:
Title
Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth
Description
Visual estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography using prior assessment or pathology for tumor type
Time Frame
15 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with primary hepatocellular carcinoma (HCC) or secondary (metastatic) carcinoma of the liver who have been referred for ultrasound-guided radiofrequency ablation (RFA) treatment Recent (within 90 days) CT or MRI scan with report of one or more tumors ≤ 1.5 cm in diameter Patient is stable and is to be managed conservatively (i.e. non-surgically) 18 years of age or older Ability and willingness to provide written informed consent Exclusion Criteria: Known or suspected cardiac shunt(s) Known sensitivity to octafluoropropane Pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P. McGahan, M.D.
Organizational Affiliation
UC Davis School of Medicine Dept. of Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

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