Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions

NCT ID: NCT04917354

Last Updated: 2021-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-18

Study Completion Date

2024-04-30

Brief Summary

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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

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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

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Hepatic Lesion

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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hepatic lesion

Superb-Microvascular imaging

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The second affilliated hospital of Zhejiang University school of medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Pintong Huang, PhD

Role: CONTACT

18857168333

Other Identifiers

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2017-025

Identifier Type: -

Identifier Source: org_study_id

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