Magnetic Resonance Imaging (MRI) in Bronchiectasis

Phase 1

• Conditions: Cystic fibrosis (CF) Non-CF Bronchiectasis; MedDRA version: 21.0 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2019-003052-36-GB
• Lead Sponsor: The University of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-28
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: A
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

For this study, eligibility criteria have been separated into workstreams as follows:
Workstream 1 – Adult Healthy Volunteers
Workstream 2 – Adults with CF
Workstream 3 – Adults with Bronchiectasis
Workstream 4 – Children aged 12 to less than 16 years with CF

Workstream 1
(Adult Healthy Volunteers)
• Aged 16 years and over
• For women, a negative urinary pregnancy test at screening and study visits
• No significant respiratory disease or other significant medical condition within the last year

Workstreams 2 and 3
(Adults with diagnosed Cystic Fibrosis or non-CF Bronchiectasis)
• Aged 16 years and over
• For women, a negative urinary pregnancy test at screening and study visits
• Diagnosis of cystic fibrosis by a respiratory physician (workstream 2) or bronchiectasis by computer tomography (CT) scan or a respiratory physician (workstream 3)
• Clinically stable as defined by respiratory care team

Workstream 4
(Paediatric patients with diagnosed Cystic Fibrosis)
• Parent or legal guardian able to give informed consent
• Aged 12 years to less than 16 years
• For females of child bearing age, a negative urinary pregnancy test at screening and study visits
• Diagnosis of cystic fibrosis by a paediatric respiratory physician
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Workstream 1
(Adult Healthy Volunteers)
• Standard MRI exclusion criteria – a history of implanted / indwelling magnetically active material
• Acute respiratory illness within 30 days of MRI
• Subject has received an Investigational Medical Product (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
• Subject not deemed fit enough to tolerate procedure
• Subject deemed unsuitable by clinical investigator for other reasons

Workstreams 2 and 3
(Adults with diagnosed Cystic Fibrosis or non-CF Bronchiectasis)
• Standard MRI exclusion criteria – a history of implanted / indwelling magnetically active material
• A current pulmonary exacerbation considered to be of sufficient severity to prevent safe MRI scanning
• Current infection or previous infection within the last 12 months with Burkholderia cepacia complex or Mycobacterium abscessus
• Previous lung transplantation
• Evidence of susceptibility to or established hypercapnic (type 2) respiratory failure
• Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
• Subject not deemed fit enough to tolerate procedure
• Subject deemed unsuitable by clinical investigator for other reasons

Workstream 4
(Paediatric patients with diagnosed Cystic Fibrosis)
• Standard MRI exclusion criteria – a history of implanted / indwelling magnetically active material
• A current pulmonary exacerbation considered to be of sufficient severity to prevent safe MRI scanning
• Current or previous infection/colonization with Burkholderia cepacia complex or Mycobacteria abscessus
• Previous lung transplantation
• Evidence of susceptibility to or established hypercapnic (type 2) respiratory failure
• Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
• Subject not deemed fit enough to tolerate procedure
• Subject deemed unsuitable by clinical investigator for other reasons

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified