To assess whether the GdMRI can fit in the annual check up.To assess whether the GdMRI is sensitive to monitor and follow up on the peripheral bronchiectasis and areas of hypoperfusion. To compare the distribution and volume of hypo perfusion on…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The ability of the radiologist and CF team to identify areas of the lung that
are hypo perfused on the Gd-MRI relative to the proton-MRI.
The distribution and volume of hypo perfused lung on the Gd-MRI will be
compared to the distribution of trapped air on the proton-MRI and with the
chest CT made in the previous year.
After completion of the study all CTs and Gd-MRIs will be scored anonymous and
in random order using a semi quantitative scoring system.
Secondary outcome
The ability of the radiologist and CF team to identify progression of
peripheral bronchiectasis compared to the CT made in the previous year.
Background summary
Traditionally pulmonary function tests have an important place in the
monitoring of CF lung disease. A major disadvantage is that they are not
sensitive to localized severe structural changes. CT is the most sensitive
technique to detect structural lung changes in CF such as bronchiectasis and
trapped air. A major disadvantage of CT is that it exposes the patient to
ionising radiation. Therefore we have restricted the use of CT to one
examination every two years. Proton-MRI was introduced in 2006 to fill in the
gap between the bi-annual CT evaluations. With proton-MRI central
bronchiectasis can well be tracked. Unfortunately, the detection of peripheral
bronchiectasis and trapped air is of relative poor quality. Fortunate, trapped
air on proton-MRI can be visualized by looking at lung perfusion since
persisting hypoventilation of areas of the lung result in matched hypo
perfusion. Lung perfusion can be visualized by MRI using intravenously injected
contrast agent Gadolinium.
Study objective
To assess whether the GdMRI can fit in the annual check up.
To assess whether the GdMRI is sensitive to monitor and follow up on the
peripheral bronchiectasis and areas of hypoperfusion. To compare the
distribution and volume of hypo perfusion on expiratory contrast enhanced
Gd-MRI to the areas of trapped air on the routine proton MRI and on the CTscan
of the previous yaer. When this is the case Gd-MRI will be added as a routine
to the MRI protocol used in CF patients. To compare the distribution and volume
of hypo perfusion on expiratory contrast enhanced Gd-MRI to PFTs parameters of
peripheral airway disease (FEF75, FEF25-75, LCI)
Study design
Parents from patients who are planned for a proton-MRI will be informed about
the study If the patient and parents agree to participate in this study the
Gd-MRI will be made on the day of the annual check up after the proton-MRI. The
routine annual blood withdrawal will be done after insertion of a peripheral
catheter. The catheter will be flushed and immobilized. During the Gd-MRI the
catheter will be used to inject the Gadolinium.Directly after the MRI
investigation the catheter will be removed.
Study burden and risks
Instead of a routine blood draw by needle a intravenous catheter will be
inserted, this is a more painful procedure therefore the patient will be
offered Emla® cream. The catheter will be used during the MRI procedure for the
injection of Gd. The Gd-MRI sequences will be added to the routine proton-MRI
protocol. This will require little extra time ( 10min).
Gadolinium is considered a safe contrast agent with a low incidence of
complications. The major complication that occurs is an allergic reaction.
Patients with severe asthma and/or allergies and patients with a known allergic
reaction on Gadolinium will be excluded. Also patients with end stage renal
disease will be excluded.
Dr. Molewaterplein 60
3015 GJ Rotterdam
Nederland
Dr. Molewaterplein 60
3015 GJ Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
inclusion criteria: signed informed consent, able to comply with protocol requirements, diagnosis of CF confirmed, age 6-18 years, stable condition, ability to perform lung function tests and breathhold manoeuvres, CT in the year before the MRI.
Exclusion criteria
Exclusion criteria: inability to follow instructions of the investigator, current respiratory infection requiring IV antibiotics, pulmonary complications that might put patient at risk to participate , claustrophobia, history of anaphylactic reaction on contrast agent, any clinical condition which, according to the treating physician, might put patient at risk, severe asthma and/or severe allergies as determined by physician.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL17489.078.07 |
| Other | trial is aangemeld bij ISRTCN helaas identificatienr nog niet ontvangen, nummer wordt u nagezonden. |