Back to resultsMRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging
Primary Purpose
Lung Diseases
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
PET/MR image acquisition
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Diseases
Eligibility Criteria
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).
Sites / Locations
- University Hospital Zurich, Department of Nuclear Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET/MR (single arm)
Arm Description
PET and MR sequence acquisition on SIGNA PET/MR device
Outcomes
Primary Outcome Measures
Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning.
Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03562806
Brief Title
MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging
Official Title
MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Tested MR sequence was inferior in preliminary evaluation
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
March 9, 2021 (Actual)
Study Completion Date
March 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
MRI 3D UTE Hyper-Cones & ZTE for PET/MR lung attenuation correction & for lung diagnostic imaging
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET/MR (single arm)
Arm Type
Experimental
Arm Description
PET and MR sequence acquisition on SIGNA PET/MR device
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/MR image acquisition
Intervention Description
Acquisition of PET and MR sequences on SIGNA PET/MR device.
Primary Outcome Measure Information:
Title
Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning.
Description
Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Huellner, M.D.
Organizational Affiliation
University Hospital, Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Department of Nuclear Medicine
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging
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