Liver DiseasesNCT04701567
Diagnostic and Evaluation of Hepato-pancreatico-biliary Disease With MRI
An observational study of Liver Diseases and Pancreas Disease, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Pancreas Disease
- What is being tested?
- Magnetic resonance imaging
- How many people
- 2,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jun 2020to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with suspicion for or diagnosed focal and/or diffuse liver or pancreatic disease who underwent MRI of the abdomen.
Who may be able to join
- 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.
Who cannot join
- Age less than 18 years.
- Lack of MRI of the abdomen.
- Inadequate image quality.
- Documented rejection to participate in research studies
Trial locations and contacts
1 site in 1 country.
Reiner contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Caecilia Reiner, MD, +41442551111
Reiner, caecilia.reiner@usz.ch
About this study
Official title: Diagnostik Und Evaluierung Hepato-pankreatiko-biliärer Erkrankungen Mittels Morphologischer Und Funktioneller Magnetresonanztomographie
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.
- Conditions
- Liver Diseases, Pancreas Disease
- Being tested
- Magnetic resonance imaging
- Medical subject headings
- Liver Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDiagnostic test
Advanced multiparametric MRI techniques to diagnose hepatic and pancreatic disease
| Study group | Role | What they receive |
|---|---|---|
| Liver disease | Not described Receives: Diagnostic Test: Magnetic resonance imaging | |
| Pancreatic disease | Not described Receives: Diagnostic Test: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathology findings in focal and/or diffuse liver disease
Pathology findings in focal and/or diffuse liver disease
Measured: 1 year
Pathology findings in focal and/or diffuse pancreatic disease
Pathology findings in focal and/or diffuse pancreatic disease
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start30 Jun 2020
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caecilia Reiner, University of Zurich
- Investigators
- Caecilia Reiner, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701567
- Sponsor's protocol ID
- BASEC ID 2020-01313
- Status last verified
- Jan 2021
- First submitted
- 6 Jan 2021
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostik Und Evaluierung Hepato-pankreatiko-biliärer Erkrankungen Mittels Morphologischer Und Funktioneller Magnetresonanztomographie
- ClinicalTrials.gov ID
- NCT04701567
- Acronym / sponsor ID
- BASEC ID 2020-01313
- Conditions
- Liver Diseases, Pancreas Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver disease | – | Diagnostic Test: Magnetic resonance imaging |
| Pancreatic disease | – | Diagnostic Test: Magnetic resonance imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicion for or diagnosed focal and/or diffuse liver or pancreatic disease who underwent MRI of the abdomen.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Age less than 18 years.
- Lack of MRI of the abdomen.
- Inadequate image quality.
- Documented rejection to participate in research studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imagingAdvanced multiparametric MRI techniques to diagnose hepatic and pancreatic disease | Diagnostic test | Liver disease, Pancreatic disease |
Primary outcome
Pathology findings in focal and/or diffuse liver disease
Time frame: 1 year
Pathology findings in focal and/or diffuse liver disease
Pathology findings in focal and/or diffuse pancreatic disease
Time frame: 1 year
Pathology findings in focal and/or diffuse pancreatic disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reiner contact
Caecilia Reiner, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Pancreas Disease, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caecilia Reiner, MD (+41442551111, caecilia.reiner@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathology findings in focal and/or diffuse liver disease (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.