Non-Invasive Characterization of Focal Liver Lesions in L... | NCT03746210

Studies
Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis

NCT03746210

Sponsor

University Hospital, Bonn

Status

Recruiting

Last Update Posted

May 18, 2022Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Liver Cirrhoses

Interventions

Standard diagnostic procedures

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Nov 14, 2018

First Submission Date that Met QC Criteria

Nov 15, 2018

First Posted Date

Nov 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2022

Last Update Posted Date

May 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Praktiknjo, Principal Investigator / Medical Doctor, University Hospital, BonnPrincipal Investigator

Lead Sponsor

University Hospital, BonnOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. The diagnostic accuracy and predictive value of non-invasive methods is studied.

Detailed Description

This study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. The diagnostic accuracy and predictive value of non-invasive methods is studied.

Upon diagnosis multiparametric ultrasound imaging of the lesions as well as sarcopenia parameters are performed for characterization of the lesions. For primary endpoint the results are then analyzed with regard to diagnostic accuracy compared to gold standard (CT, MRI or histology). For secondary endpoint, predictive value of the non-invasive diagnostics are analyzed with regards to mortality and response to treatment.

All work up, treatment and follow up are applied in standard of care fashion.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard diagnostic procedures	Diagnostic Test	B-Mode ultrasound, Duplex sonography, contrast-enhanced ultrasound, elastography, CT, MRI, anthropometrics

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy	The diagnostic accuracy of non-invasive imaging of focal liver lesions in liver cirrhosis compared to gold standard (histology, CT and/or MRI)	1 year

Secondary Outcomes

Measure	Description	Time Frame
Predictive Value	The predictive value on mortality and treatment response of non-invasive imaging of focal liver lesions in liver cirrhosis	up to 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients with focal liver lesions and liver cirrhosis

Exclusion Criteria:

no consent
under 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

This study includes all adult patients in our institution with liver cirrhosis and diagnosis of focal liver lesions. Non-invasive charaterization (multiparametric ultrasound, sarcopenia assessment) and standard of care work up, treatment and follow up is applied to all patients.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Praktiknjo, MD	Contact	+4922828715770		michael.praktiknjo@ukbonn.de
Johannes Chang, MD	Contact	+4922828715770		johannes.chang@ukbonn.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Bonn	Recruiting	Bonn			Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided