Functional lung MRI for regional treatment monitoring of patients with cystic fibrosis
| ISRCTN | ISRCTN11682934 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11682934 |
| Secondary identifying numbers | 1725-2013 |
- Submission date
- 19/06/2017
- Registration date
- 19/06/2017
- Last edited
- 19/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Department of Diagnostic and Interventional Radiology (OE 8220)
Hannover Medical School
Carl-Neuberg-Str. 1
Hannover
30625
Germany
Study information
| Study design | Case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Functional lung MRI for regional treatment monitoring of patients with cystic fibrosis: a case-control study |
| Study objectives | 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(s) | Ethics board of the Hannover Medical School (Ethikkomission der MHH), 21/02/2013, ref: 1725-2013 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Functional lung MRI parameters at baseline and 2h after treatment |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 22/08/2012 |
| Completion date | 10/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/02/2013 |
| Date of final enrolment | 10/12/2014 |
Locations
Countries of recruitment
- Germany
Study participating centre
30625
Germany
Sponsor information
University/education
Department of Diagnostic and Interventional Radiology
Carl-Neuberg-Str. 1
Hannover
30625
Germany
"ROR" |
https://ror.org/00f2yqf98 |
|---|
Funders
Funder type
Research organisation
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in 2017 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Jens Vogel-Claussen |
