ImageNCT06097741
Pulmonary MRI Using Ultra Short /Zero TE Sequences
A study testing MRI sequences in people with Image, run by IWK Health Centre at 1 site in Canada.
Trial summary
Modern imaging modalities, especially magnetic resonance imaging (MRI) have greatly advanced in recent years. Through technical advances, proton-based magnetic resonance imaging (MRI) has steadily increased in use to assess pulmonary structures in the pediatric population especially in Europe. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Image
- What is being tested?
- MRI sequences
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2023to 1 Oct 2024
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy participants (without prior history of pulmonary disease)
- Ages 3 - 18 years old
Who cannot join
- prior history of pulmonary disease
- implants
- surgeries
- pregnancy
- metal devices
- braces
- anything that would exclude them from taking an MRI
Trial locations and contacts
1 site in 1 country.
About this study
Modern imaging modalities, especially magnetic resonance imaging (MRI) have greatly advanced in recent years. Through technical advances, proton-based magnetic resonance imaging (MRI) has steadily increased in use to assess pulmonary structures in the pediatric population especially in Europe. Such technical developments have advanced by overcoming rapid decaying of transverse relaxation time and cardiac/chest movement synchronization, showing MRI to be feasible with respect to morphological and functional assessment of pulmonary impairment, in chronic lung disease such as cystic fibrosis for disease progression and prediction of exacerbation. However pulmonary imaging with MRI has also been feasible to detect pulmonary nodules in malignancies (allowing for spatial resolution).
Read the detailed description
This prospective study will enable developing/ fine tuning for an optimized ultra-short echo/zero echo MRI sequence to enable pulmonary imaging with assessment of detailed lung structures which is important in patient with chronic lung disease. This will enable radiation sparing through x-ray and computed tomography, especially reduce the accumulation dose in long term follow up imaging of patients with chronic lung disease. Also, detailed pulmonary imaging enables more detailed imaging in comparison to the standard reference of care often using radiographs, can pick up disease prior to clinical symptoms, is a useful tool to assess treatment outcome and can sometimes even prevent chronic changes by early disease diagnosis and rapid treatment. This is of particular interest in patients with chronic lung disease, such as cystic fibrosis, but also other congenital lung diseases such as congenital pulmonary airway malformation (CPAM) or malignant diseases which will otherwise have a second CT imaging to assess the lung.
The investigators will recruit healthy volunteers to assess the available MR sequences on the 1.5 T MRI scanner at the IWK health Centre in the Department of Diagnostic Imaging and either fine tune/modify the existing protocol with the help of the MRI technologist and application specialists or build a new sequence according to the most recent literature. The aim is to recruit 15 patients of different age group (aged 3- 18 years old) to assure a robust imaging protocol for all age groups. Especially, the preschool age group can be more challenging due to increased cardiac and respiratory motion, but also the understanding of the diagnostic imaging with guidance of the in house child life support as well as parental guidance and support, the possibility to watch a video on the MRI scanner to distract the patient as best as possible since the aim is to conduct the short pulmonary MRI protocol without the need for sedation.
- Conditions
- Image
- Being tested
- MRI sequences
- Keywords
- Magnetic Resonance Imaging, Sequences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI sequencesDevice
Ultra short / zero TE sequence on MRI being tested on healthy patients and improved by manually fine tuning the sequence
| Study group | Role | What they receive |
|---|---|---|
| MRI sequence | Other | patients receive an MRI Receives: Device: MRI sequences |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality
Imaging acquisition with and without breath hold is being tested and ultimately reconstruction of the acquired imaging. It will be assessed if the imaging is going to be of clinical and diagnostic standard by an experienced pediatric and pulmonary radiologist who has worked with ultra-short/zero TE sequences in clinical routine before. Here by imaging will be assessed looking at overall quality, signal, movement artifact of heart and breathing. Feasibility of preschool children to undergo imaging protocol in terms of protocol length, breathing maneuvers, general tolerability.
Measured: Image acquisition in November will undergo immediate assessment to potentially enhance imaging quality. Images will then be promptly reviewed on PACS after acquisition and post-trial termination, with parameters compared for an optimal sequence protocol.
Acquisition Time
The image acquisition is meant to take place in November and imaging will be assessed at the time of acquisition so that alteration of imaging parameters might improve imaging overall. The images itself will again be viewed on PACS shortly after acquisition and after termination of the trial imaging acquisition. Parameters will be compared to elaborate the best possible sequence protocol.
Measured: Volunteers get a call for MRI details. After 3 days, if they agree, we set imaging appointments. The PI and tech clarify, perform imaging, confirm post-exam well-being, and have a brief follow-up chat.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Dec 2023
- Primary completion20 Mar 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImageStudies of the same condition, open and under way.
- 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mareen Kraus, IWK Health Centre
- Investigators
- Mareen Kraus, MD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097741
- Sponsor's protocol ID
- 1029785
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2023
- Last updated
- 14 May 2025
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary MRI Using Ultra Short /Zero TE Sequences
- ClinicalTrials.gov ID
- NCT06097741
- Acronym / sponsor ID
- 1029785
- Conditions
- Image
- Keywords
- Magnetic Resonance Imaging, Sequences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 24 Oct 2023 (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.
Modern imaging modalities, especially magnetic resonance imaging (MRI) have greatly advanced in recent years. Through technical advances, proton-based magnetic resonance imaging (MRI) has steadily increased in use to assess pulmonary structures in the pediatric population especially in Europe. Such technical developments have advanced by overcoming rapid decaying of transverse relaxation time and cardiac/chest movement synchronization, showing MRI to be feasible with respect to morphological and functional assessment of pulmonary impairment, in chronic lung disease such as cystic fibrosis for disease progression and prediction of exacerbation. However pulmonary imaging with MRI has also been feasible to detect pulmonary nodules in malignancies (allowing for spatial resolution).
Detailed description
This prospective study will enable developing/ fine tuning for an optimized ultra-short echo/zero echo MRI sequence to enable pulmonary imaging with assessment of detailed lung structures which is important in patient with chronic lung disease. This will enable radiation sparing through x-ray and computed tomography, especially reduce the accumulation dose in long term follow up imaging of patients with chronic lung disease. Also, detailed pulmonary imaging enables more detailed imaging in comparison to the standard reference of care often using radiographs, can pick up disease prior to clinical symptoms, is a useful tool to assess treatment outcome and can sometimes even prevent chronic changes by early disease diagnosis and rapid treatment. This is of particular interest in patients with chronic lung disease, such as cystic fibrosis, but also other congenital lung diseases such as congenital pulmonary airway malformation (CPAM) or malignant diseases which will otherwise have a second CT imaging to assess the lung.
The investigators will recruit healthy volunteers to assess the available MR sequences on the 1.5 T MRI scanner at the IWK health Centre in the Department of Diagnostic Imaging and either fine tune/modify the existing protocol with the help of the MRI technologist and application specialists or build a new sequence according to the most recent literature. The aim is to recruit 15 patients of different age group (aged 3- 18 years old) to assure a robust imaging protocol for all age groups. Especially, the preschool age group can be more challenging due to increased cardiac and respiratory motion, but also the understanding of the diagnostic imaging with guidance of the in house child life support as well as parental guidance and support, the possibility to watch a video on the MRI scanner to distract the patient as best as possible since the aim is to conduct the short pulmonary MRI protocol without the need for sedation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI sequence | Other | Device: MRI sequencespatients receive an MRI |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy participants (without prior history of pulmonary disease)
- Ages 3 - 18 years old
Key exclusion criteria (7 listed)
- prior history of pulmonary disease
- implants
- surgeries
- pregnancy
- metal devices
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 |
|---|---|---|
| MRI sequencesUltra short / zero TE sequence on MRI being tested on healthy patients and improved by manually fine tuning the sequence | Device | MRI sequence |
Primary outcome
Image Quality
Time frame: Image acquisition in November will undergo immediate assessment to potentially enhance imaging quality. Images will then be promptly reviewed on PACS after acquisition and post-trial termination, with parameters compared for an optimal sequence protocol.
Imaging acquisition with and without breath hold is being tested and ultimately reconstruction of the acquired imaging. It will be assessed if the imaging is going to be of clinical and diagnostic standard by an experienced pediatric and pulmonary radiologist who has worked with ultra-short/zero TE sequences in clinical routine before. Here by imaging will be assessed looking at overall quality, signal, movement artifact of heart and breathing. Feasibility of preschool children to undergo imaging protocol in terms of protocol length, breathing maneuvers, general tolerability.
Acquisition Time
Time frame: Volunteers get a call for MRI details. After 3 days, if they agree, we set imaging appointments. The PI and tech clarify, perform imaging, confirm post-exam well-being, and have a brief follow-up chat.
The image acquisition is meant to take place in November and imaging will be assessed at the time of acquisition so that alteration of imaging parameters might improve imaging overall. The images itself will again be viewed on PACS shortly after acquisition and after termination of the trial imaging acquisition. Parameters will be compared to elaborate the best possible sequence protocol.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- 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.
Mareen Kraus, MD principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI sequences in people with Image, run by IWK Health Centre at 1 site in Canada.
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 7 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: finished, as of the sponsor's last update on 14 May 2025. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Image Quality (time frame: Image acquisition in November will undergo immediate assessment to potentially enhance imaging quality. Images will then be promptly reviewed on PACS after acquisition and post-trial termination, with parameters compared for an optimal sequence protocol.). 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 14 May 2025.