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 - Congen
Conditions
Interventions
Trade Name: hyperpolarized xenon-129
Product Name: hyperpolarized xenon-129
Pharmaceutical Form: Medicinal gas, liquefied
Sponsors
The University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
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 Inclusion criteria: (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 Inclusion criteria: (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 Inclusion criteria: (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
Exclusion criteria: Workstream 1 Exclusion criteria: (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 Exclusion criteria: (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 Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We plan to assess the value of novel MRI techniques to image the lungs of people with CF and bronchiectasis. Our main aims are to see how they compare to current measurements of lung function/structure and check that they give us useful information. Overall, we hope to identify the best MRI scanning methods for assessment of these lung diseases and employ those techniques in future clinical trials. In CF, there is great interest in newer treatments that can improve lung function. At present, we use relatively simple measures such as blowing tests to assess and monitor the efficacy of these therapies. These measurements may not always be sensitive enough to detect changes in the lungs, so newer tests that are more sensitive are required. The lung disease in bronchiectasis is similar to CF and so studying both patient groups will highlight the utility of lung MRI in a broader population. Following this study, we aim to run a clinical trial that will use our lung MRI scanning expertise ; Secondary Objective: The secondary objectives of this study are to assess how feasible the different types of MRI scans are for our participants and check how consistent the scans are between different study visits. We will perform different types of MRI scans and what we learn about participant comfort/tolerability as well as imaging quality will greatly assist in the design of future lung MRI studies. We are not sure how much the different MRI scans will change when repeated over time. As such, we will invite participants to be scanned on multiple occasions and then compare their lung images longitudinally. ;Primary end point(s): Success of acquiring 129Xe, OE and UTE MRI lung images from patients with CF and non-CF Bronchiectasis and produce baseline data for these groups to inform future clinical studies.;Timepoint(s) of evaluation of this end point: We aim to have completed r | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The same timepoints for both primary and secondary outcomes will be used (see above). ; Secondary end point(s): 1) To assess the ability of participants of each group to adhere to the protocols, thus informing the study design of future trials 2) To assess repeatability of MR outcomes across study visits for those subjects undertaking more than one MR scanning visit. | — |
Countries
United Kingdom
Contacts
Public ContactAngela Shone
The University of Nottingham
Outcome results
None listed