Lung MRI in Paediatric Lung Disease: MRI in PBB

April 29, 2026 updated by: Sheffield Children's NHS Foundation Trust

Functional and Structural Imaging of the Lung Using Hyperpolarised Gas and Proton Magnetic Resonance Imaging for the Assessment of Lung Function in Paediatrics

Protracted bacterial bronchitis (PBB) is a problem in the lungs causing children to have a wet cough for more than 4 weeks. PBB is also known to start before and cause other lung diseases and to affect children's quality of life. It is difficult to know if a child has PBB. Listening to the lungs and measuring a child's breathing are usually normal and so a bronchoscopy (looking in the lungs with a camera) and a type of lung scan called CT are needed to diagnose PBB. These tests involve children being put to sleep under anaesthetic (bronchoscopy) or exposed to radiation (CT) and so are not performed often. PBB is difficult to treat and antibiotics are given for many weeks to make children better. Often this doesn't stop the cough and antibiotics need to be injected into the child to treat the infection. Children have to take large amounts of antibiotics and have regular physiotherapy to help their cough. The only way to know if a child is better is when their parents report their cough has improved which is often unreliable. In this study we will take pictures of children's lungs using a type of scan called MRI, which is safe and does not expose children to radiation. Children breathe in a gas called xenon which fills the lungs. If there is phlegm blocking parts of the lungs, the gas cannot get through and we can see the blockage. This type of picture is the best way to measure early lung disease in children with other lung conditions such as cystic fibrosis and bronchiectasis. Measuring lung disease early will make children with PBBs lives better and mean they have to take less antibiotics. In some children, it will also help to stop lifelong lung diseases such as bronchiectasis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from the Respiratory service at Sheffield Children's Hospital. There are approximately 200 children with PBB diagnosed a year, of which 50 are aged 5 or above. The majority of these children will be eligible for inclusion in the study as most undergo bronchoscopy. It is expected that a high proportion of families will opt for their children to take part in the study due to low risks associated with the 129Xe-MRI being carried out and the benefit of additional clinical information becoming available.

Description

Inclusion Criteria:

Male and female children aged 5 to 17 years old

  • High suspicion of PBB requiring bronchoscopy
  • Be able to follow instructions
  • English speaking family member

Exclusion Criteria:

Outside of age range

  • Significant learning difficulties or inability to follow instructions
  • Informed consent / assent has not been provided
  • No English-speaking member of the family
  • Contraindications for MRI scanning

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary analysis will be to compare the measured VDP and VHI from patients with PBB to previously collated data from healthy children.
Time Frame: At time of MRI
At time of MRI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The secondary analysis will include the scoring of the presence or absence of ventilation defects from 129Xe-MRI, bronchial wall thickening/bronchiectasis, mucus plugging and gas trapping from 1H MRI, as judged by an experienced paediatric radiologist.
Time Frame: At time of MRI
At time of MRI

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Any abnormalities found will be compared against standard clinical assessments including findings on CT imaging, bronchoscopy and spirometry.
Time Frame: At time of MRI
At time of MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheffield Children's NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCH-2800

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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