Hyperpolarized Xenon Imaging in Patients With Cystic Fibrosis

NCT02912637 | Withdrawn

• 1 other identifier: P02215
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic lung diseases show a gradual onset of irreversible lung damage which can lead to severe breathing problems and/or respiratory failure. Imaging is central to guiding treatment; however, current techniques are either inaccurate or involve exposure to radiation. Recent developments in lung magnetic resonance imaging (MRI) provide promise as a radiation-free alternative. However, conventional MRI cannot directly show changes in distribution of inhaled air or absorption of gas which are important signs of early lung disease. Recently MRI imaging of the inhaled gas contrast agent Xenon has been developed which can provide this important information. This study aims to determine how Xenon MRI can help determine air flow distribution and gas uptake in the lungs. The investigators will also be able to compare the information from patients with that from healthy volunteers. This should give insight into the processes involved in chronic lung diseases and help evaluate disease extent in patients.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Lung ventilation assessed by Percentage Ventilation Defect (VD%)

  Quantitative measure of lung ventilation

  24 hours

Secondary Outcomes (5)

• Forced expiratory volume (%) in 1 second (FEV1)

  24 hours

• Percentage perfusion defect (PD%)

  24 hours

• Regional ventilation: perfusion (1-VD%)/(1-PD%) ratio

  24 hours

• CF Brody score assessed on CT in patient group

  24 hours

• Percentage ventilation defect assessed on CT (hypoattenuation) - patient group only

  24 hours

Study Arms (2)

CF patients

Hyperpolarized Xenon MRI

Other: Hyperpolarized Xenon MRI

Healthy volunteers

Hyperpolarized Xenon MRI

Other: Hyperpolarized Xenon MRI

Interventions

Hyperpolarized Xenon MRI OTHER

MRI \& MRS of lung using inhaled hyperpolarized Xenon as a contrast agent

CF patients; Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cystic fibrosis and healthy volunteers

You may qualify if:

• years or above with proven CF, and:
• Clinical stable disease over last month, defined as:
• One month without intravenous antibiotics for airways disease, and:
• One month without evidence for decrease in lung function (no evidenced drop in FEV1 or PEFR \>10%).

You may not qualify if:

• Contraindications to MR (presence of non MR compatible pacemaker, aneurysm clips, artificial heart valves, ear implants, metal fragments or metallic foreign objects in the eyes, pregnancy, and severe claustrophobia),
• Ability to breath hold below 15 seconds.
• Current (\> 6 months) smoker
• No history of acute (within the last 6 months) or chronic illness (this will be determined by direct communication with the volunteer and not from their medical records)
• As patients

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• University of Sheffield: collaborator

Study Sites (1)

Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Nicholas J Screaton

  Papworth NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 23, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)