Diagnostic and Evaluation of Hepato-pancreatico-biliary D... | NCT04701567

Studies
Diagnostic and Evaluation of Hepato-pancreatico-biliary Disease With MRI

NCT04701567

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Jan 8, 2021Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Liver Diseases
Pancreas Disease

Interventions

Magnetic resonance imaging

Countries

Switzerland

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

Jan 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2020Actual

Primary Completion Date

Dec 30, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Jan 6, 2021

First Submission Date that Met QC Criteria

Jan 6, 2021

First Posted Date

Jan 8, 2021Actual

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

Jan 6, 2021

Last Update Posted Date

Jan 8, 2021Actual

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 is a retrospective review of images from patient data. There is no recruitment necessary for this study.

Research Question: Can advanced multiparametric MRI techniques improve the detection and characterization of focal and diffuse liver disease, accurately assess treatment response and predict patient outcomes based on longitudinal monitoring? Hypotheses: Advanced multiparametric MRI techniques improve the detection, characterization and response assessment of focal and diffuse liver disease and can predict serious liver related outcomes.

Detailed Description

Not provided

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

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver disease			Diagnostic Test: Magnetic resonance imaging
Pancreatic disease			Diagnostic Test: Magnetic resonance imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Magnetic resonance imaging	Diagnostic Test	Advanced multiparametric MRI techniques to diagnose hepatic and pancreatic disease	Liver disease Pancreatic disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pathology findings in focal and/or diffuse liver disease	Pathology findings in focal and/or diffuse liver disease	1 year
Pathology findings in focal and/or diffuse pancreatic disease	Pathology findings in focal and/or diffuse pancreatic disease	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with suspicion for or diagnosed focal and/or diffuse liver or pancreatic disease who underwent MRI of the abdomen.
18 years of age and older.

Exclusion Criteria:

Age less than 18 years.
Lack of MRI of the abdomen.
Inadequate image quality.
Documented rejection to participate in research studies

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with suspicion for or diagnosed focal and/or diffuse liver or pancreatic disease who underwent MRI of the abdomen.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Caecilia Reiner, MD	Contact	+41442551111		caecilia.reiner@usz.ch
Reiner	Contact			caecilia.reiner@usz.ch

Overall Officials

Name	Affiliation	Role
Caecilia Reiner, MD	University of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich	Recruiting	Zurich		8091	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008107	Liver Diseases
D010182	Pancreatic Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided