Hepatocellular CarcinomaNCT03300401
Contrast-Enhanced Ultrasound in Diagnosing Patients With Liver Cancer Undergoing Yttrium-90 Radioembolization
A study testing Perflutren Lipid Microspheres, Sulfur Hexafluoride Lipid Microspheres and Dynamic Contrast-Enhanced Ultrasound Imaging in people with Hepatocellular Carcinoma, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Perflutren Lipid Microspheres, Sulfur Hexafluoride Lipid Microspheres and Dynamic Contrast-Enhanced Ultrasound Imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 7 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for 90Y radioembolization for HCC as part of their standard of care
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: The Role of Quantitative Contrast-Enhanced Ultrasound in Yttrium-90 (90Y) Radioembolization of Hepatocellular Carcinoma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Perflutren Lipid Microspheres, Sulfur Hexafluoride Lipid Microspheres, Dynamic Contrast-Enhanced Ultrasound Imaging, Positron Emission Tomography, Computed Tomography
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perflutren Lipid MicrospheresDrug
Also called Definity
Receive intravenous injection just prior to ultrasound
Sulfur Hexafluoride Lipid MicrospheresDrug
Also called Lumason
Receive intravenous injection just prior to ultrasound
Dynamic Contrast-Enhanced Ultrasound ImagingDevice
Also called Contrast-Enhanced Ultrasound Imaging
Undergo Contrast-Enhanced Ultrasound Imaging
Positron Emission TomographyDevice
Undergo PET/CT
Computed TomographyDevice
Also called Computerized Axial Tomography
Undergo CT scan
Yttrium-90 (90Y)Biological
Also called 90Y microsphere
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (CEUS) | Experimental | 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor response to therapy
Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start7 Nov 2017
- Primary completion7 Nov 2019 (estimated)
- Study completion7 Nov 2020 (estimated)
Why it stopped: Accrual issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Harshawn Malhi, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300401
- Sponsor's protocol ID
- 3L-17-3
- Other IDs
- NCI-2017-01422, 3L-17-3, P30CA014089
- Status last verified
- May 2019
- First submitted
- 27 Sep 2017
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Quantitative Contrast-Enhanced Ultrasound in Yttrium-90 (90Y) Radioembolization of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03300401
- Acronym / sponsor ID
- 3L-17-3
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Accrual issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 7 Nov 2019 (estimated)
- Study completion
- 7 Nov 2020 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CEUS) | Experimental | 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)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for 90Y radioembolization for HCC as part of their standard of care
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perflutren Lipid MicrospheresAlso: DefinityReceive intravenous injection just prior to ultrasound | Drug | Diagnostic (CEUS) |
| Sulfur Hexafluoride Lipid MicrospheresAlso: LumasonReceive intravenous injection just prior to ultrasound | Drug | Diagnostic (CEUS) |
| Dynamic Contrast-Enhanced Ultrasound ImagingAlso: Contrast-Enhanced Ultrasound ImagingUndergo Contrast-Enhanced Ultrasound Imaging | Device | Diagnostic (CEUS) |
| Positron Emission TomographyUndergo PET/CT | Device | Diagnostic (CEUS) |
| Computed TomographyAlso: Computerized Axial TomographyUndergo CT scan | Device | Diagnostic (CEUS) |
| Yttrium-90 (90Y)Also: 90Y microsphereGiven IV | Biological | Diagnostic (CEUS) |
Primary outcome
Local tumor response to therapy
Time frame: Up to 24 weeks
Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harshawn Malhi, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perflutren Lipid Microspheres, Sulfur Hexafluoride Lipid Microspheres and Dynamic Contrast-Enhanced Ultrasound Imaging in people with Hepatocellular Carcinoma, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor response to therapy (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.