Hepatocellular CarcinomaNCT04955119
Fusion Imaging Contrast-enhanced Ultrasound LI-RADS
A study testing Fusion imaging contrast-enhanced ultrasound in people with Hepatocellular Carcinoma, run by Tianjin Third Central Hospital at 1 site in China.
Trial summary
CEUS LI-RASD apply to lesion visible at precontrast ultrasound but not the lesion invisible. Fusion imaging can use to invisible lesions at precontrast ultrasound in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Fusion imaging contrast-enhanced ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2021to 31 Dec 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at risk for HCC(Cirrhosis or Chronic hepatitis B viral infection or Current or prior HCC) Suspicious lesions detected by CECT/MRI but not visible on conventional ultrasound and US-CECT/MRI fusion imaging Patients sign the informed consent.
Who cannot join
- Patients without risk of HCC(With cirrhosis due to congenital hepatic fibrosis or With cirrhosis due to a vascular disorder such as hereditary hemorrhagic telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion, cardiac congestion, or diffuse nodular regenerative hyperplasia) Patients without a successful registration or lesions can be seen on conventional ultrasound after successful registration Pregnancy or lactation Patients with pretreat lesion Patients don't sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Third Central Hospital
Tianjin, Tianjin Municipality, 300170
About this study
Official title: Fusion Imaging Contrast-enhanced Ultrasound LI-RADS in Patients With High-risk Hepatocellular Carcinoma With Focal Liver Lesions Invisible on Conventional Ultrasound: a Multi-center Prospective Study
CEUS LI-RASD apply to lesion visible at precontrast ultrasound but not the lesion invisible. Fusion imaging can use to invisible lesions at precontrast ultrasound in clinical practice. Thus, our aim is to explore the application value of CEUS LI-RADS in contrast-enhanced fusion imaging for focal liver lesions that are not visible on conventional ultrasound in high-risk patients with hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Fusion imaging contrast-enhanced ultrasound
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fusion imaging contrast-enhanced ultrasoundDiagnostic test
Fusion imaging contrast-enhanced ultrasound will be performed for patients with invisible lesion at conventional ultrasound.
Drug: SonoVue
| Study group | Role | What they receive |
|---|---|---|
| Fusion imaging contrast-enhanced ultrasound LI-RADS | Experimental | Fusion imaging contrast-enhanced ultrasound will be performed in patients with invisible lesion at conventional ultrasound.
Drug: SonoVue Receives: Diagnostic Test: Fusion imaging contrast-enhanced ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value
The positive predictive value = HCC in LR-5 /all lesions in LR-5
Measured: 6 months
Secondary outcomes (1)
The sensitivity and specificity of CEUS LR-5
The sensitivity and specificity are calculated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start30 Jul 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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.
- 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Third Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955119
- Sponsor's protocol ID
- dr.jingxiang003
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fusion Imaging Contrast-enhanced Ultrasound LI-RADS in Patients With High-risk Hepatocellular Carcinoma With Focal Liver Lesions Invisible on Conventional Ultrasound: a Multi-center Prospective Study
- ClinicalTrials.gov ID
- NCT04955119
- Acronym / sponsor ID
- dr.jingxiang003
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Tianjin Third Central HospitalUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 8 Jul 2021 (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.
CEUS LI-RASD apply to lesion visible at precontrast ultrasound but not the lesion invisible. Fusion imaging can use to invisible lesions at precontrast ultrasound in clinical practice. Thus, our aim is to explore the application value of CEUS LI-RADS in contrast-enhanced fusion imaging for focal liver lesions that are not visible on conventional ultrasound in high-risk patients with hepatocellular carcinoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fusion imaging contrast-enhanced ultrasound LI-RADS | Experimental | Diagnostic Test: Fusion imaging contrast-enhanced ultrasoundFusion imaging contrast-enhanced ultrasound will be performed in patients with invisible lesion at conventional ultrasound. Drug: SonoVue |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients at risk for HCC(Cirrhosis or Chronic hepatitis B viral infection or Current or prior HCC) Suspicious lesions detected by CECT/MRI but not visible on conventional ultrasound and US-CECT/MRI fusion imaging Patients sign the informed consent.
Key exclusion criteria (1 listed)
- Patients without risk of HCC(With cirrhosis due to congenital hepatic fibrosis or With cirrhosis due to a vascular disorder such as hereditary hemorrhagic telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion, cardiac congestion, or diffuse nodular regenerative hyperplasia) Patients without a successful registration or lesions can be seen on conventional ultrasound after successful registration Pregnancy or lactation Patients with pretreat lesion Patients don't sign the informed consent.
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 |
|---|---|---|
| Fusion imaging contrast-enhanced ultrasoundFusion imaging contrast-enhanced ultrasound will be performed for patients with invisible lesion at conventional ultrasound. Drug: SonoVue | Diagnostic test | Fusion imaging contrast-enhanced ultrasound LI-RADS |
Primary outcome
Positive predictive value
Time frame: 6 months
The positive predictive value = HCC in LR-5 /all lesions in LR-5
1 secondary outcome
The sensitivity and specificity of CEUS LR-5
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fusion imaging contrast-enhanced ultrasound in people with Hepatocellular Carcinoma, run by Tianjin Third Central Hospital at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Jul 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiang Jing, MD (02284112323 ext. +86, dr.jingxiang@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value (time frame: 6 months). 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 8 Jul 2021.