2024-512473-27-00
Not yet recruiting
Phase 2
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).
Cliniques Universitaires Saint-Luc1 site in 1 country15 target enrollmentStarted: September 25, 2024Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- 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).
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male and female patients at least 18 years old
- •Patients with biopsy proven or probable diagnosis of cardiac sarcoidosis based on the HRS 2014 consensus criteria
- •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
- •Male patients able to father children and female patients of childbearing potential agree to use effective methods of contraception during the study
Exclusion Criteria
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status 3 or
- •Pregnant patients / breast feeding patients.
- •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/1.73m
- •o Absolute neutrophil count <1,500 cells/mm
- •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.
- •Patients who have any other life-threatening illness, which in the opinion of the investigator would either compromise patient safety.
- •Patients at increased risk of death from a pre-existing concurrent illness with life expectancy <6 months.
- •Patients who do not speak/ understand French or Dutch.
- •Patients with contra-indications for contrast enhanced MRI and PET/CT (e.g. size, claustrophobia, known clinically relevant hypersensitivity reactions to gadolinium,…).
- •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).
Outcomes
Primary Outcomes
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).
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).
Secondary Outcomes
- 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.
Investigators
Olivier Gheysens
Scientific
Cliniques Universitaires Saint-Luc
Study Sites (1)
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