Evaluating Airway Sarcoidosis Pathology With MRI

Sarcoidosis Clinical Trial

— EASY MRI  

Official title:

EASY MRI: Evaluating Airway Sarcoidosis Pathology With MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05421975
• Other study ID #: STH21669
• Status: Recruiting
• Start date: June 28, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: April 2023
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: UoS MRI unit
• Phone: 01142159595
• Email: mriresearch[@]sheffield.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sarcoidosis is a condition where inflamed cells clump together to form granulomas, which can lead to inflammation or scarring. It can affect any organ of the body, but most commonly affects the lungs. Symptoms can be highly variable, and some patients have no symptoms where as others may develop fatigue or breathlessness. The causes of sarcoidosis are poorly understood. It commonly affects adults in their 30's or 40's.

Some patients present with symptoms suggestive of involvement in the airways, such as cough. Inhalers containing steroid are commonly used, but there is a poor understanding of which patients may benefit. Part of the problem is the lack of a sensitive way of measuring these effects and knowledge of how sarcoidosis affects the airways physiologically.

The investigators would like to know more about the disease process of sarcoidosis, particularly where it involves the airways. This study will use a number of techniques in order to better understand to disease process.

In order to assess whether sarcoidosis produces changes in airway ventilation (and whether these changes are stable or change over a short time period). This pilot study aims to recruit 6 patients who will have magnetic resonance imaging (MRI) with inhaled xenon gas. During this technique, xenon and nitrogen mixture is inhaled and during a subsequent breath-hold, images of the lungs are taken. This creates a detailed view of the lung airway tree, to explore how the disease affects the airways and deeper lung tissue.

This technique will be used alongside lung function tests, commonly performed in the laboratory setting and cardiopulmonary exercise testing, to see what happens in the lungs of this group of patients when they reach peak exercise capacity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of sarcoidosis

• Sarcoidosis clinician diagnoses airways involvement

• Aged 18 and above

Exclusion Criteria:

• Current combustible cigarette or electronic cigarette user

• Significant doubt over the diagnosis of sarcoidosis

• Asthma or other airways disease, requiring regular inhaler use

• Contraindication to MRI identified on safety questionnaire

• Recent COVID-19 infection (lateral flow or PCR swab positive within the last 28 days) or ongoing symptoms from COVID-19

Related Conditions & MeSH terms

• Sarcoidosis

Locations

Country	Name	City	State
United Kingdom	University MRI Unit	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic. (1)	Ventilation defect percentage (VDP) - a measure of amount of the lung which goes unventilated	12 weeks
Primary	Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic.(2)	Ventilation Coefficient of variation (CV) - a measure of ventilation heterogeneity	12 weeks
Primary	Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic. (3)	Apparent diffusion coefficient (ADC) and mean linear intercept (LmD) - measurements of the Brownian motion of gas in the acinar airways and surrogate measures of acinar integrity.	12 weeks
Primary	Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic. (4)	Red blood cell to tissue plasma ratio (RBC:TP) - a measure of the efficiency of gas exchange across the alveoli into the blood.	12 weeks