SarcoidosisEASY MRINCT05421975
Evaluating Airway Sarcoidosis Pathology With MRI
An observational study of Sarcoidosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis
- How many people
- 2 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2021to 22 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Sarcoidosis patients aged over 18. Non-smokers with no other airways disease or contraindication to MRI.
Who may be able to join
- Clinical diagnosis of sarcoidosis
- Sarcoidosis clinician diagnoses airways involvement
- Aged 18 and above
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EASY MRI: Evaluating Airway Sarcoidosis Pathology With MRI
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.
Read more
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.
- Conditions
- Sarcoidosis
- Medical subject headings
- Sarcoidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start28 Jun 2021
- Primary completion22 Aug 2023
- Study completion22 Aug 2023
Why it stopped: Unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421975
- Sponsor's protocol ID
- STH21669
- Acronym
- EASY MRI
- Status last verified
- Apr 2025
- First submitted
- 6 Jun 2022
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EASY MRI: Evaluating Airway Sarcoidosis Pathology With MRI
- ClinicalTrials.gov ID
- NCT05421975
- Acronym / sponsor ID
- EASY MRI / STH21669
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 22 Aug 2023 (actual)
- Study completion
- 22 Aug 2023 (actual)
- First posted
- 16 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Sarcoidosis patients aged over 18. Non-smokers with no other airways disease or contraindication to MRI.
Key inclusion criteria (3 listed)
- Clinical diagnosis of sarcoidosis
- Sarcoidosis clinician diagnoses airways involvement
- Aged 18 and above
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic. (1)
Time frame: 12 weeks
Ventilation defect percentage (VDP) - a measure of amount of the lung which goes unventilated
Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic.(2)
Time frame: 12 weeks
Ventilation Coefficient of variation (CV) - a measure of ventilation heterogeneity
Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic. (3)
Time frame: 12 weeks
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.
Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic. (4)
Time frame: 12 weeks
Red blood cell to tissue plasma ratio (RBC:TP) - a measure of the efficiency of gas exchange across the alveoli into the blood.
Results and safety
The study was stopped early (reason given: Unable to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does endobronchial sarcoidosis produce changes, which are appreciable on ventilation MRI and are they temporally stochastic or deterministic. (1) (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.