- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06097741
Pulmonary MRI Using Ultra Short /Zero TE Sequences
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy participants (without prior history of pulmonary disease)
- Ages 3 - 18 years old
Exclusion Criteria:
- prior history of pulmonary disease
- implants
- surgeries
- pregnancy
- metal devices
- braces
- anything that would exclude them from taking an MRI
Study Plan
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 |
|---|---|
|
Other: MRI sequence
patients receive an MRI
|
Ultra short / zero TE sequence on MRI being tested on healthy patients and improved by manually fine tuning the sequence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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
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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mareen Kraus, MD, IWK Health Centre
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1029785
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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