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Accuracy for Imaging Cardiac Sarcoidosis with 68Ga-Pentixafor Positron Emission Tomography/Computed Tomography (68Ga-Pentixafor PET/CT): ASPECT study

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523646-27-00
Enrollment
20
Registered
2026-02-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Sarcoidosis

Brief summary

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.

Detailed description

The amount of 68Ga-Pentixafor uptake in the myocardium is scored by the Qualification Visual Score for Hypermetabolism (QVSH) o 0 = None (no or less uptake than in the mediastinum) o 1 = Mild (more uptake than in the mediastinum, less than in the liver) o 2 = Moderate (more uptake than in the liver) o 3 = Severe (intense uptake), 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 1 = No uptake o 2 = Diffuse uptake o 3 = Focal uptake o 4 = 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)., The standardized uptake values (SUV) is scored for quantitative assessment of tracer uptake(19)., Myocardial suppression will be scored as: • Fully suppressed (no uptake) • Low (more than mediastinal, less than liver) • Intermediate (more than liver uptake) • High focal (much more than liver, focal) • High diffuse (much more than liver, diffuse), Two experienced observers will analyze the images, and findings will be compared., Presence of uptake in other organs suspected for sarcoidosis will be scored, including information on the affected organ., Time-activity curves will be used to study perfusion characteristics of the tracer.

Interventions

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
The amount of 68Ga-Pentixafor uptake in the myocardium is scored by the Qualification Visual Score for Hypermetabolism (QVSH) o 0 = None (no or less uptake than in the mediastinum) o 1 = Mild (more uptake than in the mediastinum, less than in the liver) o 2 = Moderate (more uptake than in the liver) o 3 = Severe (intense uptake), 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 1 = No uptake o 2 = Diffuse uptake o 3 = Focal uptake o 4 = 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)., The standardized uptake values (SUV) is scored for quantitative assessment of tracer uptake(19)., Myocardial suppression will be scored as: • Fully suppressed (no uptake) • Low (more than mediastinal, less than liver) •

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 13, 2026