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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37541

Enrollment

Registered

2012-08-14

Start date

2012-05-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: sarcoidosis with a pulmonary (parenchymatous) localisation

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Presence of active inflammation in the pulmonary parenchyma as assessed by DWI, compared to the gold standard using a qualitative assessment (positive or negative for presence of disease activity).	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results