GALLIUM (68GA); PENTIXAFOR for Cardiac sarcoidosis

Inclusion criteria

• {"criterion_text":"- Adult patients (aged 18 years or older)\n- Consensus diagnosis of extracardiac sarcoidosis\n- Patients with (suspected) cardiac sarcoidosis referred for a clinically indicated 18F-FDG PET/CT"}

Exclusion criteria

• {"criterion_text":"- Medical history of other known cardiac infectious or inflammatory disease\n- (Possible) pregnancy in pre-menopausal women\n- Refusal to be informed about potential additional PET/CT findings.\n- Inability to provide informed consent"}

Primary endpoints

• {"endpoint_text":"- Sensitivity and specificity of 68Ga-Pentixafor PET/CT in patients with (suspected) cardiac sarcoidosis. Standard of care 18F-FDG PET/CT is the reference test.","definition_or_measurement_approach":"Primary measure: sensitivity and specificity of 68Ga-Pentixafor PET/CT using standard-of-care 18F-FDG PET/CT as the reference test."}

Secondary endpoints

• {"endpoint_text":"- The amount of 68Ga-Pentixafor uptake in the myocardium is scored by the Qualification Visual Score for Hypermetabolism (QVSH) o\t0 = None (no or less uptake than in the mediastinum) o\t1 = Mild (more uptake than in the mediastinum, less than in the liver) o\t2 = Moderate (more uptake than in the liver) o\t3 = Severe (intense uptake)","definition_or_measurement_approach":"Visual scoring of myocardial tracer uptake using the Qualification Visual Score for Hypermetabolism (QVSH) with categories 0–3 as specified."}
• {"endpoint_text":"- In case of abnormal uptake the pattern (focal, focal on diffuse or diffuse), extent, and exact location(s) of uptake is described for the left and right ventricle(19). Scoring for the uptake pattern is as follows: o\t1 = No uptake o\t2 = Diffuse uptake o\t3 = Focal uptake o\t4 = Focal on diffuse uptake If the uptake in the myocardium is focal or focal on diffuse, the location is scored according to a validated LV segmental scoring system(20).","definition_or_measurement_approach":"Describe uptake pattern (no/diffuse/focal/focal on diffuse) and, if focal or focal on diffuse, score location using a validated left ventricular segmental scoring system."}
• {"endpoint_text":"- The standardized uptake values (SUV) is scored for quantitative assessment of tracer uptake(19).","definition_or_measurement_approach":"Quantitative assessment using standardized uptake values (SUV)."}
• {"endpoint_text":"- Myocardial suppression will be scored as: •\tFully suppressed (no uptake) •\tLow (more than mediastinal, less than liver) •\tIntermediate (more than liver uptake) •\tHigh focal (much more than liver, focal) •\tHigh diffuse (much more than liver, diffuse)","definition_or_measurement_approach":"Myocardial suppression categories as listed (Fully suppressed, Low, Intermediate, High focal, High diffuse) to be applied to images."}
• {"endpoint_text":"- Two experienced observers will analyze the images, and findings will be compared.","definition_or_measurement_approach":"Interobserver comparison: image reads by two experienced observers with comparison of findings (interobserver agreement assessment)."}
• {"endpoint_text":"- Presence of uptake in other organs suspected for sarcoidosis will be scored, including information on the affected organ.","definition_or_measurement_approach":"Score presence of tracer uptake in other organs suspected of sarcoidosis and record the affected organ(s)."}
• {"endpoint_text":"- Time-activity curves will be used to study perfusion characteristics of the tracer.","definition_or_measurement_approach":"Use time-activity curves to analyse perfusion characteristics of the tracer."}

Netherlands

Earliest CTIS Part Ii Submission Date

04-02-2026

Latest Decision Or Authorization Date

12-02-2026

Processing Time Days

8

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands