Contrast Media, Liver, Biopsy, FusionNCT04487288
Added Value in Combined Use of Fusion Imaging and Contrast-enhanced Ultrasonography
A study testing SONAZOID in people with Contrast Media, Liver, Biopsy, Fusion, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
So far, there have been studies showing that the CEUS-grafted technique has added value in biopsy and RFA, but no studies have compared the group using only fusion and the group using CEUS+fusion. Therefore, the additional added value of CEUS will be evaluated by comparing the two groups. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Contrast Media, Liver, Biopsy, Fusion
- What is being tested?
- SONAZOID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jun 2020to 30 Dec 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for ultrasound biopsy to confirm local liver lesions
- Adults over 18
- Patients who underwent multi-phasic liver CT or MRI within 6 weeks prior to the procedure
- Patients who understand and agree to the explanation and consent form and submit the consent form
Who cannot join
- Non-adaptive patients with ultrasound contrast agents (eg acute respiratory failure, heart disease, egg allergy, pregnant women, lactating women)
- Those who have difficulty obtaining proper liver ultrasound images A. Patient cooperation is not possible B. If it is difficult to obtain an image that is appropriate for the researcher's judgment (atrophy of the right lobe of the liver, a bowel is located between the liver and the abdominal wall, etc.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jeong Min Lee, MD, PhD
About this study
Official title: Added Value in Combined Use of Fusion Imaging and Contrast-enhanced Ultrasonography Compared to Fusion Imaging Alone for Percutaneous Biopsies of Focal Liver Lesions
So far, there have been studies showing that the CEUS-grafted technique has added value in biopsy and RFA, but no studies have compared the group using only fusion and the group using CEUS+fusion. Therefore, the additional added value of CEUS will be evaluated by comparing the two groups.
Read the detailed description
Despite the rapid development of tumor markers and liver imaging, pathological confirmation is still necessary for atypical liver lesions that do not meet imaging criteria. US guided procedures are widely used as a method to identify focal lesions of the liver pathologically, and these US guided procedures have no burden on the operation, can be easily accessed, and have a lower cost than surgery. However, the frequency of pathological confirmation with this US guided procedure remains at around 90%. In order to increase this probability, a technique for fusion of liver CT/MRI and US has been widely used in recent years, and this allows accurate targeting of small lesions through structures seen in CT and MR. Through the fusion technique, the biopsy success rate for focal lesions can be increased to 94.4%. However, there are many cases where lesions deeply located in patients with cirrhosis are invisible, and biopsy is difficult only with fusion due to poor sonic window in patients with high BMI. To this end, a technique called contrast-enhanced ultrasonography (CEUS), such as the fusion technique, was added, which is a technique that can identify tumor vascularity in real-time using second-generation contrast media. In recent studies, there are studies combining this fusion technique and CEUS technique, and the success rate of these techniques varies from 87.6% to 97.5%. Although CEUS with fusion techniques are theoretically superior to fusion only technique, the use of CEUS adds cost of contrast media and is limited in patients with side effects on contrast media. . Also, there is no study comparing the two so far, and this study intends to compare the technique combining CEUS and fusion and the technique using only fusion.
- Conditions
- Contrast Media, Liver, Biopsy, Fusion
- Being tested
- SONAZOID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SONAZOIDDiagnostic test
CEUS using SONAZOID with fusion technique
| Study group | Role | What they receive |
|---|---|---|
| CEUS with fusion | Experimental | Control group: The historic cohort is used to compare the results of the biopsy using fusion only technique from 2013 to 2019. Receives: Diagnostic Test: SONAZOID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy yield rate
Yield rate
Measured: about 2weeks
Secondary outcomes (5)
Complication rate
Complication rate
Measured: about 2days
Tumor visibility on B-mode US
Tumor visibility on B-mode US which divided into 1 (no visualization), 2 (poorly visible), 3 (indistinct), and 4 (clearly visible)
Measured: immediately
Evaluation of safety access routes to avoid complication
Evaluate whether the needle has a safety route that can prevent complication by avoiding vessels or bile ducts in the liver.
Measured: Time: immediately
Tumor vascularity on CEUS
The tumor vascularity is evaluated by CEUS (hyper, iso, hypo vascularity on arterial phase), and compared to contrast enhancement on the CT or MRI
Measured: Time: immediately
Subjective evaluation on the success of the procedure
Immediately after the procedure, the reliability of appropriate tissue collection for the viable portion is determined and recorded. A score of 3-4 means that operator is expecting a successful enough tissue harvest, and a score of 1-2 means operator is not expecting proper tissue collection.
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start2 Jun 2020
- Primary completion1 Mar 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Media, Liver, Biopsy, FusionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Liver Cancer Association
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, PhD, Principal investigator, Seoul National University Hospital, Radiology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487288
- Sponsor's protocol ID
- H-2003-044-1108
- Status last verified
- Apr 2021
- First submitted
- 20 Jul 2020
- Last updated
- 8 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value in Combined Use of Fusion Imaging and Contrast-enhanced Ultrasonography Compared to Fusion Imaging Alone for Percutaneous Biopsies of Focal Liver Lesions
- ClinicalTrials.gov ID
- NCT04487288
- Acronym / sponsor ID
- H-2003-044-1108
- Conditions
- Contrast Media, Liver, Biopsy, Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korean Liver Cancer Association
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 27 Jul 2020 (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.
So far, there have been studies showing that the CEUS-grafted technique has added value in biopsy and RFA, but no studies have compared the group using only fusion and the group using CEUS+fusion. Therefore, the additional added value of CEUS will be evaluated by comparing the two groups.
Detailed description
Despite the rapid development of tumor markers and liver imaging, pathological confirmation is still necessary for atypical liver lesions that do not meet imaging criteria. US guided procedures are widely used as a method to identify focal lesions of the liver pathologically, and these US guided procedures have no burden on the operation, can be easily accessed, and have a lower cost than surgery. However, the frequency of pathological confirmation with this US guided procedure remains at around 90%. In order to increase this probability, a technique for fusion of liver CT/MRI and US has been widely used in recent years, and this allows accurate targeting of small lesions through structures seen in CT and MR. Through the fusion technique, the biopsy success rate for focal lesions can be increased to 94.4%. However, there are many cases where lesions deeply located in patients with cirrhosis are invisible, and biopsy is difficult only with fusion due to poor sonic window in patients with high BMI. To this end, a technique called contrast-enhanced ultrasonography (CEUS), such as the fusion technique, was added, which is a technique that can identify tumor vascularity in real-time using second-generation contrast media. In recent studies, there are studies combining this fusion technique and CEUS technique, and the success rate of these techniques varies from 87.6% to 97.5%. Although CEUS with fusion techniques are theoretically superior to fusion only technique, the use of CEUS adds cost of contrast media and is limited in patients with side effects on contrast media. . Also, there is no study comparing the two so far, and this study intends to compare the technique combining CEUS and fusion and the technique using only fusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CEUS with fusion | Experimental | Diagnostic Test: SONAZOIDControl group: The historic cohort is used to compare the results of the biopsy using fusion only technique from 2013 to 2019. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for ultrasound biopsy to confirm local liver lesions
- Adults over 18
- Patients who underwent multi-phasic liver CT or MRI within 6 weeks prior to the procedure
- Patients who understand and agree to the explanation and consent form and submit the consent form
Key exclusion criteria (2 listed)
- Non-adaptive patients with ultrasound contrast agents (eg acute respiratory failure, heart disease, egg allergy, pregnant women, lactating women)
- Those who have difficulty obtaining proper liver ultrasound images A. Patient cooperation is not possible B. If it is difficult to obtain an image that is appropriate for the researcher's judgment (atrophy of the right lobe of the liver, a bowel is located between the liver and the abdominal wall, etc.)
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 |
|---|---|---|
| SONAZOIDCEUS using SONAZOID with fusion technique | Diagnostic test | CEUS with fusion |
Primary outcome
Biopsy yield rate
Time frame: about 2weeks
Yield rate
5 secondary outcomes
Complication rate
Time frame: about 2days
Tumor visibility on B-mode US
Time frame: immediately
Evaluation of safety access routes to avoid complication
Time frame: Time: immediately
Tumor vascularity on CEUS
Time frame: Time: immediately
Subjective evaluation on the success of the procedure
Time frame: immediately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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.
Jeong Min Lee, MD, PhD principal investigator
Seoul National University Hospital, Radiology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SONAZOID in people with Contrast Media, Liver, Biopsy, Fusion, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 2 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 Apr 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 South Korea. 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 SAE JIN PARK, MD (+82-2072-3107 ext. 3107, psjko05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biopsy yield rate (time frame: about 2weeks). 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 Apr 2021.