- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03562806
MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging
May 16, 2022 updated by: University of Zurich
MRI 3D UTE Hyper-Cones & ZTE for PET/MR lung attenuation correction & for lung diagnostic imaging
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The primary objective is to clinically test the feasibility of 3D UTE Hyper-Cones & ZTE in capturing lung density of patients with lung diseases at reasonable clinical imaging times compared to standard MR lung protocols (LAVA-Flex, PROPELLER).
Secondly, we want to investigate if Hyper-Cones & ZTE can be used for lung imaging such as vessels and air-pathways, oncological patients, lung nodules and lung infiltration & parenchyma pathophysiology such as chronic obstructive pulmonary disease.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Zurich, Switzerland, 8091
- University Hospital Zurich, Department of Nuclear Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- informed consent and signature
- clinical PET/CT planned and performed at Wagi site in Schlieren
- male or female patients
- from 18 to 80 years of age.
Exclusion Criteria:
- same exclusion criteria as for the clinical PET/CT exam (i.e. pregnant women).
Additional exclusion criteria:
- standard exclusion criteria for clinical MRI (evaluated by clinical standard determined by MRI questionnaire).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PET/MR (single arm)
PET and MR sequence acquisition on SIGNA PET/MR device
|
Acquisition of PET and MR sequences on SIGNA PET/MR device.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning.
Time Frame: 1 year
|
Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin Huellner, M.D., University Hospital, Zürich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2018
Primary Completion (Actual)
March 9, 2021
Study Completion (Actual)
March 9, 2021
Study Registration Dates
First Submitted
May 23, 2018
First Submitted That Met QC Criteria
June 7, 2018
First Posted (Actual)
June 20, 2018
Study Record Updates
Last Update Posted (Actual)
May 23, 2022
Last Update Submitted That Met QC Criteria
May 16, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-00899
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.