Value of MRI - DWI in Assessment of Disease Activity in pulmonary parenchymatous lokalization of Sarcoidosis

Phase 2

Conditions: Sarcoidosis
10024967

Registration Number: NL-OMON37541

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

sarcoidosis with a pulmonary (parenchymatous) localisation

Exclusion Criteria

- Asymptomatic patient
- Co-existing pulmonary or medastinal pathology (malignancy, pneumonia)
- Contra-indications for MRI, for example:
* MRI incompatible pacemaker
* MRI incompatible insulin pump or nerve stimulator
* MRI incompatible prosthetic heart valve
* vascular clips
* ossicular chain prosthesis
- Doubt regarding the diagnosis of sarcoidosis
- Immune suppressive therapy
- Renal insufficiency (glomerular infiltration rate < 60 ml/min)
- Pregnancy or breast feeding

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Presence of active inflammation in the pulmonary parenchyma as assessed by DWI,<br /><br>compared to the gold standard using a qualitative assessment (positive or<br /><br>negative for presence of disease activity). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pulmonary parenchymatous lesions:<br /><br>- ADC values (MRI: DWI)<br /><br>- Contrast ratio consolidation / paraspinal muscle (MRI: STIR)<br /><br>- SUV max (FDG-PET)<br /><br>- enhancement characteristics<br /><br><br /><br>Mediastinal and hilar lymph nodes:<br /><br>- Presence of disease activity in mediastinal and hilar lymph nodes as assessed<br /><br>by DWI<br /><br>- ADC value (MRI: DWI)<br /><br>- Correlation of contrast ratio consolidation / paraspinal muscle (MRI: STIR).<br /><br>- SUV max (FDG-PET)<br /><br><br /><br>Evaluation of false positive and false negative results. </p><br>