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Contrast-Enhanced Ultrasound in Diagnosing Patients With Liver Cancer Undergoing Yttrium-90 Radioembolization
The Role of Quantitative Contrast-Enhanced Ultrasound in Yttrium-90 (90Y) Radioembolization of Hepatocellular Carcinoma
3 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedStudy Start
First participant enrolled
November 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 7, 2020
CompletedMay 16, 2019
May 1, 2019
2 years
September 27, 2017
May 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Local tumor response to therapy
Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.
Up to 24 weeks
Study Arms (1)
Diagnostic (CEUS)
EXPERIMENTALPatients 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.
Interventions
Receive intravenous injection just prior to ultrasound
Receive intravenous injection just prior to ultrasound
Undergo Contrast-Enhanced Ultrasound Imaging
Undergo CT scan
Eligibility Criteria
You may qualify if:
- Patients scheduled for 90Y radioembolization for HCC as part of their standard of care
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harshawn Malhi, MD
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2017
First Posted
October 3, 2017
Study Start
November 7, 2017
Primary Completion
November 7, 2019
Study Completion
November 7, 2020
Last Updated
May 16, 2019
Record last verified: 2019-05