Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions

June 7, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The second affilliated hospital of Zhejiang University school of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population consisted of patients (age:18-80 years) with visible hepatic lesion on US

Description

Inclusion Criteria:

  1. Visible hepatic lesion on US
  2. Agree to participate in the study
  3. Accessible follow-up imaging or pathological results

Exclusion Criteria:

1. Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hepatic lesion
Device: Superb-Microvascular imaging
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
diagnostic accuracy
Time Frame: 1 week preoperatively
1 week preoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2017

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

June 2, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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