NANOBODY AGAINST MACROPHAGE MANNOSE RECEPTOR, CONJUGATED WITH 1,4,7-TRIAZACYCLONONANE-N,N',N''-TRIACETIC ACID, LABELLED WITH GALLIUM GA-68 for Cardiac sarcoidosis

Inclusion criteria

• {"criterion_text":"- Male and female patients at least 18 years old"}
• {"criterion_text":"- Patients with biopsy proven or probable diagnosis of cardiac sarcoidosis based on the HRS 2014 consensus criteria"}
• {"criterion_text":"- Having available the following historical diagnostic images: o 18F-FDG PET/CT scan (Standard of care), not older than 1 month prior to screening, with patchy pattern consistent of CS o 13N-NH3 PET/CT scan (Standard of care), not older than 1 month prior to screening"}
• {"criterion_text":"- Male patients able to father children and female patients of childbearing potential agree to use effective methods of contraception during the study"}

Exclusion criteria

• {"criterion_text":"- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 3 or 4."}
• {"criterion_text":"- Pregnant patients / breast feeding patients."}
• {"criterion_text":"- Patients with inadequate organ function, suggested by the following laboratory results drawn at screening: o Significantly impaired renal function defined as estimated GFR <30 ml/min/1.73m2. o Absolute neutrophil count <1,500 cells/mm3. o Total bilirubin >1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome). o Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) >3.0 x ULN."}
• {"criterion_text":"- Patients who have any other life-threatening illness, which in the opinion of the investigator would either compromise patient safety."}
• {"criterion_text":"- Patients at increased risk of death from a pre-existing concurrent illness with life expectancy <6 months."}
• {"criterion_text":"- Patients who do not speak/ understand French or Dutch."}
• {"criterion_text":"- Patients with contra-indications for contrast enhanced MRI and PET/CT (e.g. size, claustrophobia, known clinically relevant hypersensitivity reactions to gadolinium,…)."}
• {"criterion_text":"- Patients with any other condition that in the opinion of the investigator may significantly interfere with study compliance (including but not limited to psychological or psychiatric, social or geographical condition potentially hampering compliance with the study requirements)."}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Defined as focal/patchy uptake pattern of 68Ga-NOTA-Anti-MMR-VHH2 above background activity consistent with sarcoid involvement; outcome measured as proportion of patients meeting this imaging criterion among those with histological or clinical 'probable' cardiac sarcoidosis."}

Secondary endpoints

• {"endpoint_text":"- Incidence rate of all adverse events (AEs) and serious AEs (SAEs) detected during the study procedures.","definition_or_measurement_approach":"Incidence rate of AEs and SAEs observed/detected during study procedures, measured as counts and rates during study follow-up."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Comparison of semi-quantitative PET indices (SUVmax and target-to-background ratio) between imaging modalities/agents."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion of patients with uptake above background in sarcoidosis-related lesions, compared against late gadolinium enhancement (LGE) lesions on cardiac MRI."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Proportion of patients with uptake above background compared to histological confirmation of M2 macrophages where biopsy data are available."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Proportion of patients showing decreased or normalized tracer uptake after corticosteroid (CS) treatment, compared with FDG PET/CT and cardiac MRI findings."}
• {"endpoint_text":"- Proportion of patients with anti-drug antibodies (ADA) against 68Ga-NOTA-Anti- MMR-VHH2.","definition_or_measurement_approach":"Proportion of patients with detectable anti-drug antibodies (ADA) against the investigational tracer, measured by immunogenicity assays."}

Belgium

Earliest CTIS Part Ii Submission Date

09-09-2024

Latest Decision Or Authorization Date

25-09-2024

Processing Time Days

16

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Cliniques Universitaires Saint-Luc

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"BioWin","duties_or_roles":"Monetary support","organisation_type":""}