NCT04917354

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2017

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

7 years

First QC Date

June 2, 2021

Last Update Submit

June 7, 2021

Conditions

Keywords

Superb Micro-vascular ImagingHepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • diagnostic accuracy

    1 week preoperatively

Study Arms (1)

hepatic lesion

Device: Superb-Microvascular imaging

Interventions

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

hepatic lesion

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Visible hepatic lesion on US
  • Agree to participate in the study
  • Accessible follow-up imaging or pathological results

You may not qualify if:

  • \. Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affilliated hospital of Zhejiang University school of medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Pintong Huang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 8, 2021

Study Start

April 18, 2017

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations