Lung DiseasesNCT03562806
MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging
A study testing PET/MR image acquisition in people with Lung Diseases, run by University of Zurich at 1 site in Switzerland.
Trial summary
MRI 3D UTE Hyper-Cones \& ZTE for PET/MR lung attenuation correction \& for lung diagnostic imaging Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- PET/MR image acquisition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 May 2018to 9 Mar 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Department of Nuclear Medicine
Zurich, 8091
About this study
MRI 3D UTE Hyper-Cones \& ZTE for PET/MR lung attenuation correction \& for lung diagnostic imaging
Read the 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.
- Conditions
- Lung Diseases
- Being tested
- PET/MR image acquisition
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MR image acquisitionDiagnostic test
Acquisition of PET and MR sequences on SIGNA PET/MR device.
| Study group | Role | What they receive |
|---|---|---|
| PET/MR (single arm) | Experimental | PET and MR sequence acquisition on SIGNA PET/MR device Receives: Diagnostic Test: PET/MR image acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 posted20 Jun 2018
- Study start23 May 2018
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
Why it stopped: Tested MR sequence was inferior in preliminary evaluation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Huellner, M.D., Principal investigator, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562806
- Sponsor's protocol ID
- 2017-00899
- Other IDs
- 2017
- Status last verified
- May 2022
- First submitted
- 23 May 2018
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging
- ClinicalTrials.gov ID
- NCT03562806
- Acronym / sponsor ID
- 2017-00899
- Conditions
- Lung Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Tested MR sequence was inferior in preliminary evaluation
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 23 May 2018 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 20 Jun 2018 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/MR (single arm) | Experimental | Diagnostic Test: PET/MR image acquisitionPET and MR sequence acquisition on SIGNA PET/MR device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- same exclusion criteria as for the clinical PET/CT exam (i.e. pregnant women).
- standard exclusion criteria for clinical MRI (evaluated by clinical standard determined by MRI questionnaire).
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 |
|---|---|---|
| PET/MR image acquisitionAcquisition of PET and MR sequences on SIGNA PET/MR device. | Diagnostic test | PET/MR (single arm) |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Tested MR sequence was inferior in preliminary evaluation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- 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.
Martin Huellner, M.D. principal investigator
University Hospital, Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MR image acquisition in people with Lung Diseases, 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 23 May 2022. 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?
The study was stopped early (reason given: Tested MR sequence was inferior in preliminary evaluation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning. (time frame: 1 year). 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 23 May 2022.