Phase II study to assess in vivo imaging of MMR-expressing macrophages in cardiac sarcoidosis using 68Ga-NOTA-Anti-MMR-VHH2 Positron Emission Tomography (PET).
interventional
N/A
1 country
1
Evaluate the ability of in vivo 68Ga-NOTA-Anti-MMR-VHH2 PET/CT imaging to detect cardiac sarcoid lesions in patients with histological or clinical ‘probable’ diagnosis of cardiac sarcoidosis based on the HRS 2014 criteria including a patchy pattern on FDG-PET/CT consistent with cardiac sarcoidosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2024
Actual (reported)Proportion of patients with (historical) histological proven or clinical ‘probable’ diagnosis of cardiac sarcoidosis (defined by HRS 2024 consensus recommendations) confirmed by 68Ga-NOTA-Anti- MMR-VHH2 (defined as focal/patchy uptake pattern of 68Ga-NOTA-Anti-MMR-VHH2 above background activity consistent with sarcoid involvement).
Incidence rate of all adverse events (AEs) and serious AEs (SAEs) detected during the study procedures.
Comparison of semi-quantitative PET indices (SUVmax and Target-to-background ratio) between 68Ga-NOTA-Anti-MMR-VHH2 and FDG-PET/CT patients with cardiac sarcoidosis.
Proportion of patients with confirmed 68Ga-NOTA-Anti-MMR-VHH2 uptake (defined as 68Ga-NOTA-Anti-MMR-VHH2uptake above background activity) in sarcoidosisrelated lesions compared to LGE lesions on cardiac MRI.
Proportion of patients with confirmed 68Ga-NOTA-Anti-MMR-VHH2 uptake (defined as 68Ga-NOTA-Anti-MMR-VHH2uptake above background activity) in sarcoidosisrelated lesions is compared to histologically confirmed presence of M2 macrophages (if available).
Proportion of patients with decreased or normalized of 68Ga-NOTA-Anti-MMR-VHH2 uptake (representing presence of MMR expressing macrophages) in sarcoidosisrelated lesions after CS treatment compared to FDG PET/CT and cMRI.
Cliniques Universitaires Saint-Luc
Sint-Lambrechts-Woluwe, 1200, Belgium
Olivier Gheysens
First Submitted
July 1, 2024
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Source retrieved:
A Trial of Baricitinib in Patients With Cardiac Sarcoidosis
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