To develop an innovative magnetic resonance imaging (MRI) protocol(M-ILD) for accurate phenotyping and sensitive monitoring of therapy in ILD patients.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Interstitiele longziekten (Interstitial Lung Disease, ILD)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Amount of fibrotic and inflammatory lung on chest CT and chest MRI. Response to
treatment according to pulmonary function test (PFT) change.
Secondary outcome
- To correlate CT and MRI findings with ILD blood biomarkers and lung function
test
- To assess whether photon counting chest CT (photon counting CT) is superior
to standard CT in terms of resolution, dose reduction and quantification of
lung fibrosis
Background summary
Interstitial lung diseases (ILDs) are a heterogeneous group of severe and
sometimes progressive lung diseases with high impact on patients* quality of
life and survival. Treatment depends on ILD subtype. Most ILDs are initially
treated with immunosuppression with mixed response, but a progressive fibrosing
(PF-) ILD phenotype (despite immunosuppression) is treated with effective but
expensive anti-fibrotic therapy. Accurate initial discrimination between
inflammation and fibrosis needed to select the best initial therapy is
difficult with current monitoring tools, which are Computed Tomography (CT) and
pulmonary function tests (PFTs).
Study objective
To develop an innovative magnetic resonance imaging (MRI) protocol(M-ILD) for
accurate phenotyping and sensitive monitoring of therapy in ILD patients.
Study design
Prospective longitudinal study
Study burden and risks
ILD patients newly diagnosed in the multidisciplinary ILD meeting of the
pneumology department either with a predominant fibrotic or inflammatory ILD,
will be asked to participate in the study and perform chest MRI, a low-dose
chest CT and blood examination at baseline. Both examinations chest MRI and
low-dose chest CT will be performed on the same days to reduce patient*s burden
and unnecessary visit to the hospital. Chest MRI examination with M-ILD
protocol will last maximum 60 minutes. Within 30 minutes of chest MRI, each
patient will undergo to a non-contrast low-dose chest-CT. The same protocol
will be repeated at the yearly follow-up to assess treatment effect. The I-ILD
group will have a routine evaluation at 3 months, according to standard
clinical care, including an additional chest-MRI. In a subgroup of patients
(n=12) from the PF-ILD (n=6) and I-ILD (n=6) groups, we will perform PET-MRI
with the standard FDG radiotracer to quantify inflammation and active
fibrosis.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Multidisciplinary diagnosis of PF-ILD (progressive fibrotic ILD group
including IPF) OR inflammatory ILD (including idiopathic NSIP, ILD related to
connective tissue disease or with autoimmune features or chronic
hypersensitivity pneumonitis (IGr).
- Informed consent
- About to start treatment for their ILD. Each patient will be treated as
decided in the MDT according to standard clinical practice. PF-ILD and IPF
group are usually treated with anti-fibrotic drugs (nintedanib or pirfenidone).
The I-ILD group are treated with anti-inflammatory therapy, such as prednisone,
mycophenolate mofetil, azathioprine, rituximab.
Additional inclusion criteria for subgroup of ILD patients who undergo FDG
PET-MRI:
PF-ILD group:
- Patients of PF-ILD group with sign of disease activity as indicated by PFT
and symptoms (dyspnea, exercise capacity, cough)
I-ILD group:
- Patients of I-ILD group with sign of disease activity as indicated by and
symptoms (dyspnea, exercise capacity, cough)
Exclusion criteria
- Contra-indications or inability to undergo MRI (i.e. claustrophobia.)
- Current lung infection (according to treating physician)
- Respiratory distress at rest despite oxygen
- Contra-indication to use gadolinium contrast (severe renal insufficiency,
estimated glomerular filtration rate [eGFR] <30 mL/min per 1.73 m2)(28)
- Previous allergic reaction to gadolinium or iodinated contrast media
- Acute ILD exacerbations at baseline
- High flow chronic oxygen need(respiratory distress at rest despite oxygen)
- Lung cancer at baseline
- For PF-ILD group: previous treatment with anti-fibrotic medications
- For I-ILD group: previous treatment with anti-inflammatory medications
Additional exclusion criteria for subgroup of ILD patients who undergo FDG
PET-MRI:
PF-ILD group:
- Ongoing treatment with anti-fibrotic modulators at baseline
I-ILD group:
- Ongoing treatment with anti-inflammatory and/or immunomodulators at baseline
Design
Recruitment
Medical products/devices used
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 | NL78614.078.22 |