Plain English Summary
Background and study aims
Cystic fibrosis is an inherited disease in which the lungs and digestive system become clogged with mucus. Magnetic resonance imaging (MRI) is a type of scan that produces detailed images of the inside of the body. The aim of this study is to test lung MRI techniques in patients with cystic fibrosis and to monitor the immediate effects of breathing in hypertonic saline (a strong salt solution) compared with clinical routine lung function tests.
Who can participate?
Patients aged between 12 and 24 with cystic fibrosis
What does the study involve?
All patients undergo an MRI scan, a lung function test, and oxygen measurements. Then they receive a treatment with inhaled hypertonic saline to produce sputum. Within 2 hours after treatment, another MRI scan is performed. After this MRI scan the participants undergo another lung function test and oxygen measurements. Apart from the MRI scan all other tests are part of the routine clinical outpatient visit.
What are the possible benefits and risks of participating?
There is no benefit to the participant. MRI is a clinically established way of obtaining images of organs and tissues without using radiation. The contrast media used to increase contrast in MRI rarely causes allergic reaction. Side effects of inhalation of hypertonic saline are coughing, a sore throat and chest tightness due to an initial irritation of the airways.
Where is the study run from?
Hannover Medical School (Germany)
When is the study starting and how long is it expected to run for?
August 2012 to December 2014
Who is funding the study?
1. Ernst-August Schrader Stipend (Germany)
2. German Center for Lung Research (Germany)
Who is the main contact?
Prof. Jens Vogel-Claussen
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1725-2013
Study information
Scientific title
Functional lung MRI for regional treatment monitoring of patients with cystic fibrosis: a case-control study
Acronym
Study hypothesis
To evaluate if quantitative functional lung MRI parameters can detect changes in regional lung function two hours after a single hypertonic saline treatment in comparison to spirometry and multiple breath washout.
Ethics approval
Ethics board of the Hannover Medical School (Ethikkomission der MHH), 21/02/2013, ref: 1725-2013
Study design
Case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Cystic fibrosis
Intervention
All patients receive a pre-treatment MRI scan, lung function test, and oxygen saturation measurements during their outpatient day visit. Then they receive a treatment with inhaled hypertonic saline (7%) on the same day according to the SOP 530.00 of the TDV (Therapeutic Diagnostic Network of the Cystic Fibrosis Foundation) to produce induced sputum. Within 2 hours post treatment, a post-treatment MRI scan will be performed. After this MRI scan the patient will receive another lung function test and oxygen saturation measurements on the same day. Apart from the MRI scan all other tests are part of the routine clinical outpatient visit. During each MRI scan 0.03 mmol/kg Dotarem will be administered i.v. for lung perfusion imaging. During each MRI scan the patient will receive 100% oxygen at a flow rate of 15 l/min for about 10 min.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Functional lung MRI parameters at baseline and 2h after treatment
Secondary outcome measures
No secondary outcome measures
Overall trial start date
22/08/2012
Overall trial end date
10/12/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with cystic fibrosis
2. Aged between 12 and 24
3. Patients must be in a clinically stable condition with a confirmed diagnosis of cystic fibrosis
4. The forced expiratory volume in one second (FEV1) must have a minimum volume of >40 percent predicted for age and gender at the pre MRI lung function test
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Pregnant or breastfeeding women
2. Cigarette smokers
3. Patients with hypertonic saline treatment (HST) within the last 7 days
4. Contraindications to MRI or contrast media (allergy to MRI or CT contrast media, GFR< 30 mL/min/1.73 m2)
5. No (patient or parental) consent to participate
Recruitment start date
21/02/2013
Recruitment end date
10/12/2014
Locations
Countries of recruitment
Germany
Trial participating centre
Hannover Medical School
Hannover
30625
Germany
Funders
Funder type
Research organisation
Funder name
Ernst-August Schrader Stipend
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
German Center for Lung Research
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in 2017
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Jens Vogel-Claussen
Intention to publish date
31/12/2017
Participant level data
Available on request
Results - basic reporting
Publication summary