Hepatocellular Carcinoma (HCC)NCT03267290
Comparing Diagnostic Accuracy for Liver Tumours Between the Combination of CEUS and CEMRI Versus CECT and CEMRI
A study testing Sonazoid- CEUS, CEMRI, CECT in people with Hepatocellular Carcinoma (HCC), run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Hepatocellular carcinoma (HCC) is unique regarding diagnosis because the clinical diagnosis without pathology proof is accepted. The dynamic image, including contrast-enhanced computed tomography (CECT) and contrast-enhanced magnetic resonance image (CEMRI) were recognized in many guidelines for diagnosing the HCC. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- Sonazoid- CEUS, CEMRI, CECT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2017to 11 Jan 2019
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-70
- All patients presented with newly diagnosed liver lesion(s) with initial impression of malignancy.
- Lesions no larger than 3cm in diameter.
- Signed and dated informed consent
Who cannot join
- The lesion with previously documented histology
- The lesion previously treated with Percutaneous Ethanol Injection, Radiofrequency Ablation, or Transarterial Chemoembolization
- The lesion will not have histological confirmation after differential diagnosis
- The subject had known hypersensitivity to any component of Sonazoid, including a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral or laryngeal swelling, hypotension or shock).
- The subject was considered to be unsuitable to participate in the study by the investigator.
- The subject was known to have a right-to-left shunt, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension.
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- The subject had a recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within the last 7 days, significant worsening of cardiac symptoms within the last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of electrocardiogram, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders.
- The subject had adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
- The subject had known thrombosis within the liver, or portal, or mesenteric veins.
- The patient with iodine/Gd allergy, lower epidermal growth factor receptor level(<50), liver/renal dysfunction, and other condition that unsuitable to receive contrast
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Clinical Study for Comparing Diagnostic Accuracy for Liver Tumours Between the Combination of Contrast-enhanced Ultrasound and Contrast-enhanced Magnetic Resonance Imaging Versus Contrast-enhanced Computed Tomography and CEMRI
Hepatocellular carcinoma (HCC) is unique regarding diagnosis because the clinical diagnosis without pathology proof is accepted. The dynamic image, including contrast-enhanced computed tomography (CECT) and contrast-enhanced magnetic resonance image (CEMRI) were recognized in many guidelines for diagnosing the HCC. In contrast to the CT and MRI, ultrasound (US) with/without contrast is suggested by several societies as the sufficient surveillance modality. The contrast-enhanced ultrasound (CEUS) has aroused more attentions regarding the rapid improvement of contrast medium. In this study, the investigators conducted a prospective, single-center, open-label trial to compare the efficacy and safety of CEUS + CEMRI in characterizing HCC, in comparison with CECT + CEMRI.
Read the detailed description
The liver cancers including hepatocellular carcinoma (HCC) resulted in more than 7,000 mortalities in Taiwan every year. HCC is unique regarding diagnosis because the clinical diagnosis without pathology proof is accepted. The dynamic image, including contrast-enhanced computed tomography (CECT) and contrast-enhanced magnetic resonance image (CEMRI) were recognized in many guidelines for diagnosing the HCC including Taiwan National Health insurance. Currently established guidelines endorse 3-phasic CT and MRI as first-line modalities. In contrast to the CT and MRI, ultrasound (US) with/without contrast is suggested by several societies as the most sufficient surveillance modality. However, the advantage of US in liver cirrhosis with regenerative nodules is only 32-65% in sensitivity.
The contrast-enhanced ultrasound (CEUS) has aroused more attentions regarding the rapidly improvement of contrast medium. In addition to Italian association for the study of the liver, the Japan society has documented CEUS as an integral part in the diagnosis algorism. Two phases, i.e. vascular phase and Kupffer phase, could be interpreted with second generation contrast agents, Sonazoid, for differentiating liver tumors. For liver tumor that failed to present washout phase in CECT or CEMRI, CEUS might be helpful because a tumor lack of contrast uptake in the Kupffer phase is favouring HCC. However, previous reports were confined to retrospective studies or small population, and more solid evidence is required to identify the diagnosis feasibility of CEUS with specific contrast agent.
In this study, the investigators conducted a prospective, single-center, open-label trial to compare the efficacy and safety of CEUS + CEMRI in characterizing HCC, in comparison with CECT + CEMRI. 60 patients with liver tumours no larger than 3cm in diameter will be enrolled, and tumour specimen will be obtained after imaging examination by tumour resection or biopsy. The primary endpoint is the sensitivity and specificity between the study groups, use the histology as reference diagnosis. The secondary endpoints include (1) the sensitivity and specificity of CEUS+CECT, CECT+CEMRI in differential diagnosis of liver tomours as malignant or benign, use the histology as reference diagnosis, (2) adverse effects, (3) vital signs (blood pressure, heart rate), and (4) laboratory values (the hematologic, renal and hepatic function change). Our exploratory endpoint is the detection rate of CEUS+CEMRI, CECT+CEMRI, use the histology as reference diagnosis.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- Sonazoid- CEUS, CEMRI, CECT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonazoid- CEUS, CEMRI, CECTDiagnostic test
Sonazoid- CEUS+CEMRI in a characterization of HCC, in comparison with CECT+CEMRI.
| Study group | Role | What they receive |
|---|---|---|
| Sonazoid- CEUS+CEMRI or CECT+CEMRI | Experimental | Comparing Diagnostic Accuracy for Liver Tumours Between the Combination of CEUS and CEMRI Versus CECT and CEMRI Receives: Diagnostic Test: Sonazoid- CEUS, CEMRI, CECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of the blinded read of CEUS+CEMRI and CECT+CEMRI in characterization of HCC
the 95% two-sided confidence interval will be presented for both sensitivity and specificity in characterization of HCC
Measured: up to 1 year
Secondary outcomes (1)
The sensitivity and specificity of the blinded read of CEUS+CEMRI and CECT+CEMRI in differential diagnosis of liver tumours
the 95% two-sided confidence interval will be presented for both sensitivity and specificity in differential diagnosis of liver tumours
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Jul 2017
- Primary completion29 Nov 2018
- Study completion11 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai-Wen Huang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267290
- Sponsor's protocol ID
- 201706079MIPA
- Status last verified
- Jun 2019
- First submitted
- 27 Aug 2017
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- 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 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study for Comparing Diagnostic Accuracy for Liver Tumours Between the Combination of Contrast-enhanced Ultrasound and Contrast-enhanced Magnetic Resonance Imaging Versus Contrast-enhanced Computed Tomography and CEMRI
- ClinicalTrials.gov ID
- NCT03267290
- Acronym / sponsor ID
- 201706079MIPA
- Conditions
- Hepatocellular Carcinoma (HCC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 30 Aug 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.
Hepatocellular carcinoma (HCC) is unique regarding diagnosis because the clinical diagnosis without pathology proof is accepted. The dynamic image, including contrast-enhanced computed tomography (CECT) and contrast-enhanced magnetic resonance image (CEMRI) were recognized in many guidelines for diagnosing the HCC. In contrast to the CT and MRI, ultrasound (US) with/without contrast is suggested by several societies as the sufficient surveillance modality. The contrast-enhanced ultrasound (CEUS) has aroused more attentions regarding the rapid improvement of contrast medium. In this study, the investigators conducted a prospective, single-center, open-label trial to compare the efficacy and safety of CEUS + CEMRI in characterizing HCC, in comparison with CECT + CEMRI.
Detailed description
The liver cancers including hepatocellular carcinoma (HCC) resulted in more than 7,000 mortalities in Taiwan every year. HCC is unique regarding diagnosis because the clinical diagnosis without pathology proof is accepted. The dynamic image, including contrast-enhanced computed tomography (CECT) and contrast-enhanced magnetic resonance image (CEMRI) were recognized in many guidelines for diagnosing the HCC including Taiwan National Health insurance. Currently established guidelines endorse 3-phasic CT and MRI as first-line modalities. In contrast to the CT and MRI, ultrasound (US) with/without contrast is suggested by several societies as the most sufficient surveillance modality. However, the advantage of US in liver cirrhosis with regenerative nodules is only 32-65% in sensitivity.
The contrast-enhanced ultrasound (CEUS) has aroused more attentions regarding the rapidly improvement of contrast medium. In addition to Italian association for the study of the liver, the Japan society has documented CEUS as an integral part in the diagnosis algorism. Two phases, i.e. vascular phase and Kupffer phase, could be interpreted with second generation contrast agents, Sonazoid, for differentiating liver tumors. For liver tumor that failed to present washout phase in CECT or CEMRI, CEUS might be helpful because a tumor lack of contrast uptake in the Kupffer phase is favouring HCC. However, previous reports were confined to retrospective studies or small population, and more solid evidence is required to identify the diagnosis feasibility of CEUS with specific contrast agent.
In this study, the investigators conducted a prospective, single-center, open-label trial to compare the efficacy and safety of CEUS + CEMRI in characterizing HCC, in comparison with CECT + CEMRI. 60 patients with liver tumours no larger than 3cm in diameter will be enrolled, and tumour specimen will be obtained after imaging examination by tumour resection or biopsy. The primary endpoint is the sensitivity and specificity between the study groups, use the histology as reference diagnosis. The secondary endpoints include (1) the sensitivity and specificity of CEUS+CECT, CECT+CEMRI in differential diagnosis of liver tomours as malignant or benign, use the histology as reference diagnosis, (2) adverse effects, (3) vital signs (blood pressure, heart rate), and (4) laboratory values (the hematologic, renal and hepatic function change). Our exploratory endpoint is the detection rate of CEUS+CEMRI, CECT+CEMRI, use the histology as reference diagnosis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonazoid- CEUS+CEMRI or CECT+CEMRI | Experimental | Diagnostic Test: Sonazoid- CEUS, CEMRI, CECTComparing Diagnostic Accuracy for Liver Tumours Between the Combination of CEUS and CEMRI Versus CECT and CEMRI |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 20-70
- All patients presented with newly diagnosed liver lesion(s) with initial impression of malignancy.
- Lesions no larger than 3cm in diameter.
- Signed and dated informed consent
Key exclusion criteria (11 listed)
- The lesion with previously documented histology
- The lesion previously treated with Percutaneous Ethanol Injection, Radiofrequency Ablation, or Transarterial Chemoembolization
- The lesion will not have histological confirmation after differential diagnosis
- The subject had known hypersensitivity to any component of Sonazoid, including a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral or laryngeal swelling, hypotension or shock).
- The subject was considered to be unsuitable to participate in the study by the investigator.
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 |
|---|---|---|
| Sonazoid- CEUS, CEMRI, CECTSonazoid- CEUS+CEMRI in a characterization of HCC, in comparison with CECT+CEMRI. | Diagnostic test | Sonazoid- CEUS+CEMRI or CECT+CEMRI |
Primary outcome
The sensitivity and specificity of the blinded read of CEUS+CEMRI and CECT+CEMRI in characterization of HCC
Time frame: up to 1 year
the 95% two-sided confidence interval will be presented for both sensitivity and specificity in characterization of HCC
1 secondary outcome
The sensitivity and specificity of the blinded read of CEUS+CEMRI and CECT+CEMRI in differential diagnosis of liver tumours
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Kai-Wen Huang, MD, PhD principal investigator
National Taiwan University Hospital
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- CEUS, CEMRI, CECT in people with Hepatocellular Carcinoma (HCC), run by National Taiwan University Hospital at 1 site in Taiwan.
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 11 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: finished, as of the sponsor's last update on 1 Jul 2020. 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 Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The sensitivity and specificity of the blinded read of CEUS+CEMRI and CECT+CEMRI in characterization of HCC (time frame: up to 1 year). 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 1 Jul 2020.