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).

Cardiac sarcoidosis

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., Proportion of patients with anti-drug antibodies (ADA) against 68Ga-NOTA-Anti- MMR-VHH2.

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