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出境医 / 临床实验 / Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions

Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions

Study Description
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

Condition or disease Intervention/treatment
Hepatic Lesion Device: Superb-Microvascular imaging

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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: iBEAM-Based Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024
Arms 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
Outcome Measures
Primary Outcome Measures :
  1. diagnostic accuracy [ Time Frame: 1 week preoperatively ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population consisted of patients (age:18-80 years) with visible hepatic lesion on US
Criteria

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

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Pintong Huang, PhD 18857168333 huangpintong@126.com

Locations
Layout table for location information
China, Zhejiang
The second affilliated hospital of Zhejiang University school of medicine Recruiting
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Tracking Information
First Submitted Date June 2, 2021
First Posted Date June 8, 2021
Last Update Posted Date June 8, 2021
Actual Study Start Date April 18, 2017
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2021) 		diagnostic accuracy [ Time Frame: 1 week preoperatively ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions
Official Title iBEAM-Based Superb Micro-vascular Imaging for Evaluation of Hepatic Lesions
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
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The population consisted of patients (age:18-80 years) with visible hepatic lesion on US
Condition Hepatic Lesion
Intervention 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
Study Groups/Cohorts hepatic lesion
Intervention: Device: Superb-Microvascular imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 7, 2021) 		150
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2024
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pintong Huang, PhD 18857168333 huangpintong@126.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04917354
Other Study ID Numbers 2017-025
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators Not Provided
Investigators Not Provided
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date June 2021