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Contrast-Enhanced Ultrasound in Diagnosing Patients With Liver Cancer Undergoing Yttrium-90 Radioembolization

Primary Purpose

Hepatocellular Carcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Perflutren Lipid Microspheres
Sulfur Hexafluoride Lipid Microspheres
Dynamic Contrast-Enhanced Ultrasound Imaging
Positron Emission Tomography
Computed Tomography
Yttrium-90 (90Y)
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Patients scheduled for 90Y radioembolization for HCC as part of their standard of care

Exclusion Criteria:

  • Patients who have already received tumor treatment (either systemic or loco-regional such as previous Y90RE, microwave or radiofrequency [RF] ablation or transarterial chemoembolization [TACE])
  • Pregnant or nursing
  • Known cardiac shunt
  • Known pulmonary hypertension
  • History of hypersensitivity to Definity (perflutren lipid microsphere) or Lumason
  • History of hypersensitivity to iodinated contrast agent
  • Cannot consent for himself or herself

Sites / Locations

  • USC/Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (CEUS)

Arm Description

Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo PET/CT after standard of care 90Y radioembolization at baseline.

Outcomes

Primary Outcome Measures

Local tumor response to therapy
Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2017
Last Updated
May 14, 2019
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03300401
Brief Title
Contrast-Enhanced Ultrasound in Diagnosing Patients With Liver Cancer Undergoing Yttrium-90 Radioembolization
Official Title
The Role of Quantitative Contrast-Enhanced Ultrasound in Yttrium-90 (90Y) Radioembolization of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Accrual issue
Study Start Date
November 7, 2017 (Actual)
Primary Completion Date
November 7, 2019 (Anticipated)
Study Completion Date
November 7, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot clinical trial studies how well contrast-enhanced ultrasound in diagnosing patients with liver cancer who are undergoing Yttrium-90 radioembolization. Contrast-enhanced ultrasound may provide detailed imaging of the tumor arteries after the injection of a contrast-agent consisting of microbubbles, and may predict how much Yttrium-90 will deposit in the tumor.
Detailed Description
PRIMARY OBJECTIVES: I. Investigate the relationship between hepatocellular carcinoma (HCC) tumor perfusion on pre-procedural contrast-enhanced ultrasound (CEUS) time intensity curve (TIC) and post-procedural Yttrium-90 (90Y) microsphere distribution after 90Y radioembolization (RE). SECONDARY OBJECTIVES: I. Study the potential of serial CEUS TIC examinations as a marker of tumor treatment response as assessed at 20 - 24 week computed tomography (CT) follow-up. OUTLINE: Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo positron emission tomography/computed tomography (PET/CT) after standard of care 90Y radioembolization at baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (CEUS)
Arm Type
Experimental
Arm Description
Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo PET/CT after standard of care 90Y radioembolization at baseline.
Intervention Type
Drug
Intervention Name(s)
Perflutren Lipid Microspheres
Other Intervention Name(s)
Definity
Intervention Description
Receive intravenous injection just prior to ultrasound
Intervention Type
Drug
Intervention Name(s)
Sulfur Hexafluoride Lipid Microspheres
Other Intervention Name(s)
Lumason
Intervention Description
Receive intravenous injection just prior to ultrasound
Intervention Type
Device
Intervention Name(s)
Dynamic Contrast-Enhanced Ultrasound Imaging
Other Intervention Name(s)
Contrast-Enhanced Ultrasound Imaging
Intervention Description
Undergo Contrast-Enhanced Ultrasound Imaging
Intervention Type
Device
Intervention Name(s)
Positron Emission Tomography
Intervention Description
Undergo PET/CT
Intervention Type
Device
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
Computerized Axial Tomography
Intervention Description
Undergo CT scan
Intervention Type
Biological
Intervention Name(s)
Yttrium-90 (90Y)
Other Intervention Name(s)
90Y microsphere
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Local tumor response to therapy
Description
Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for 90Y radioembolization for HCC as part of their standard of care Exclusion Criteria: Patients who have already received tumor treatment (either systemic or loco-regional such as previous Y90RE, microwave or radiofrequency [RF] ablation or transarterial chemoembolization [TACE]) Pregnant or nursing Known cardiac shunt Known pulmonary hypertension History of hypersensitivity to Definity (perflutren lipid microsphere) or Lumason History of hypersensitivity to iodinated contrast agent Cannot consent for himself or herself
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harshawn Malhi, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Contrast-Enhanced Ultrasound in Diagnosing Patients With Liver Cancer Undergoing Yttrium-90 Radioembolization

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