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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03300401
Recruitment Status : Withdrawn (Accrual issue)
First Posted : October 3, 2017
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Perflutren Lipid Microspheres Drug: Sulfur Hexafluoride Lipid Microspheres Device: Dynamic Contrast-Enhanced Ultrasound Imaging Device: Positron Emission Tomography Device: Computed Tomography Biological: Yttrium-90 (90Y) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Quantitative Contrast-Enhanced Ultrasound in Yttrium-90 (90Y) Radioembolization of Hepatocellular Carcinoma
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : November 7, 2019
Estimated Study Completion Date : November 7, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium

Arm Intervention/treatment
Experimental: Diagnostic (CEUS)
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.
Drug: Perflutren Lipid Microspheres
Receive intravenous injection just prior to ultrasound
Other Name: Definity

Drug: Sulfur Hexafluoride Lipid Microspheres
Receive intravenous injection just prior to ultrasound
Other Name: Lumason

Device: Dynamic Contrast-Enhanced Ultrasound Imaging
Undergo Contrast-Enhanced Ultrasound Imaging
Other Name: Contrast-Enhanced Ultrasound Imaging

Device: Positron Emission Tomography
Undergo PET/CT

Device: Computed Tomography
Undergo CT scan
Other Name: Computerized Axial Tomography

Biological: Yttrium-90 (90Y)
Given IV
Other Name: 90Y microsphere




Primary Outcome Measures :
  1. Local tumor response to therapy [ Time Frame: Up to 24 weeks ]
    Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.



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:

  • 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

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): NCT03300401


Locations
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United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Harshawn Malhi, MD University of Southern California
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03300401    
Other Study ID Numbers: 3L-17-3
NCI-2017-01422 ( Registry Identifier: Registry ID: CTRP (Clinical Trial Reporting Program) )
3L-17-3 ( Other Identifier: USC/Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.: Yes
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases