Hepatic LesionNCT04917354
Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions
An observational study of Hepatic Lesion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Superb Micro-vascular Imaging (SMI) based on the iBeam platform is used to evaluate the blood supply of solid tumors. Compared with color Doppler technology, the sensitivity, accuracy and consistency of the ability of SMI to display blood flow are evaluated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Lesion
- What is being tested?
- Superb-Microvascular imaging
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2017to Apr 2024
- Phase
- Observational
- 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
Study population: The population consisted of patients (age:18-80 years) with visible hepatic lesion on US
Who may be able to join
- Visible hepatic lesion on US
- Agree to participate in the study
- Accessible follow-up imaging or pathological results
Who cannot join
- 1. Pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affilliated hospital of Zhejiang University school of medicine
Hangzhou, Zhejiang
About this study
Official title: iBEAM-Based Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions
Superb Micro-vascular Imaging (SMI) based on the iBeam platform is used to evaluate the blood supply of solid tumors. Compared with color Doppler technology, the sensitivity, accuracy and consistency of the ability of SMI to display blood flow are evaluated. Thus, the investigators will use Superb-Microvascular imaging (SMI, Toshiba, Japan) for diagnosing hepatic lesions, which enable to detect slow micro vascular flow inside the tumor
Read the detailed description
To evaluate the diagnostic accuracy of SMI (primary outcome) when applying on the hepatic lesion.
Each US findings during exam for patients with hepatic lesion were recorded by radiologist.
Sample size calculation according to the primary outcome.
- Conditions
- Hepatic Lesion
- Being tested
- Superb-Microvascular imaging
- Keywords
- Superb Micro-vascular Imaging, Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superb-Microvascular imagingDevice
Device: Superb-Microvascular imaging Superb-Microvascular imaging: new sonographic software technique on ultrasonography to detect low-vascular flow without use of contrast media for ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| hepatic lesion | Not described Receives: Device: Superb-Microvascular imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy
Measured: 1 week preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start18 Apr 2017
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic LesionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917354
- Sponsor's protocol ID
- 2017-025
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iBEAM-Based Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions
- ClinicalTrials.gov ID
- NCT04917354
- Acronym / sponsor ID
- 2017-025
- Conditions
- Hepatic Lesion
- Keywords
- Superb Micro-vascular Imaging, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 8 Jun 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.
Superb Micro-vascular Imaging (SMI) based on the iBeam platform is used to evaluate the blood supply of solid tumors. Compared with color Doppler technology, the sensitivity, accuracy and consistency of the ability of SMI to display blood flow are evaluated. Thus, the investigators will use Superb-Microvascular imaging (SMI, Toshiba, Japan) for diagnosing hepatic lesions, which enable to detect slow micro vascular flow inside the tumor
Detailed description
To evaluate the diagnostic accuracy of SMI (primary outcome) when applying on the hepatic lesion.
Each US findings during exam for patients with hepatic lesion were recorded by radiologist.
Sample size calculation according to the primary outcome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hepatic lesion | – | Device: Superb-Microvascular imaging |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population consisted of patients (age:18-80 years) with visible hepatic lesion on US
Key inclusion criteria (3 listed)
- Visible hepatic lesion on US
- Agree to participate in the study
- Accessible follow-up imaging or pathological results
Key exclusion criteria (1 listed)
- 1. Pregnant women
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 |
|---|---|---|
| Superb-Microvascular imagingDevice: Superb-Microvascular imaging Superb-Microvascular imaging: new sonographic software technique on ultrasonography to detect low-vascular flow without use of contrast media for ultrasonography | Device | hepatic lesion |
Primary outcome
diagnostic accuracy
Time frame: 1 week preoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Lesion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 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 Jun 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 Pintong Huang, PhD (18857168333, huangpintong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy (time frame: 1 week preoperatively). 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 Jun 2021.