NCT06097741

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

May 14, 2025

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 13, 2023

Last Update Submit

May 9, 2025

Conditions

Keywords

Magnetic Resonance ImagingSequences

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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.

Study Arms (1)

MRI sequence

OTHER

patients receive an MRI

Device: MRI sequences

Interventions

Ultra short / zero TE sequence on MRI being tested on healthy patients and improved by manually fine tuning the sequence

MRI sequence

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy participants (without prior history of pulmonary disease)
  • Ages 3 - 18 years old

You may not qualify if:

  • prior history of pulmonary disease
  • implants
  • surgeries
  • pregnancy
  • metal devices
  • braces
  • anything that would exclude them from taking an MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Study Officials

  • Mareen Kraus, MD

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 24, 2023

Study Start

December 1, 2023

Primary Completion

March 20, 2024

Study Completion

October 1, 2024

Last Updated

May 14, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations