Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/06/2017
Date assigned
19/06/2017
Last edited
19/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Jens Vogel-Claussen

ORCID ID

Contact details

Department of Diagnostic and Interventional Radiology (OE 8220)
Hannover Medical School
Carl-Neuberg-Str. 1
Hannover
30625
Germany

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

Sponsor information

Organisation

Hannover Medical School

Sponsor details

Department of Diagnostic and Interventional Radiology
Carl-Neuberg-Str. 1
Hannover
30625
Germany

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes