BridgeMD
Study on the detection of cardiac inflammation by PET-CT imaging with a new tracer called '68Ga-NOTA-Anti-MMR-VHH2' in patients with cardiac sarcoidosis.
EU CTIS ID: 2024-512473-27-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 3 or 4.
- 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/1.73m2. 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.
- 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.
See the full eligibility 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
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status 3 or 4.
- 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/1.73m2. 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.
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.