Accuracy of 68Ga-Pentixafor PET/CT for the Imaging of Cardiac Sarcoidosis: The ASPECT Study

The primary objective of this pilot study is to evaluate the diagnostic accuracy of 68Ga-Pentixafor positron emission tomography/computed tomography (PET/CT) in imaging cardiac sarcoidosis. The secondary objectives include the assessment of pathological myocardial tracer uptake, physiological myocardial uptake, and interobserver agreement regarding the PET/CT findings. Additionally, the investigation will evaluate tracer uptake in other organs affected by the disease.

The sponsor did not provide information regarding the total number of participants. The study population consists of adult patients, including both males and females, within specific age ranges. Participants must have a consensus diagnosis of extracardiac sarcoidosis. The cohort includes individuals with suspected cardiac sarcoidosis who have been referred for a clinically indicated 18F-FDG PET/CT.

This phase 4, diagnostic clinical trial is a pilot study designed to evaluate the accuracy of [68Ga]Ga-Pentixafor positron emission tomography/computed tomography (PET/CT) for imaging cardiac sarcoidosis. The primary objective is to determine the sensitivity and specificity of the test compared to the standard of care, 18F-FDG PET/CT. Eligible participants include adults with a consensus diagnosis of extracardiac sarcoidosis who are referred for a clinically indicated 18F-FDG PET/CT. The methodology involves the intravenous administration of a 200 MBq/kg dose of [68Ga]Ga-Pentixafor. Secondary endpoints include the assessment of myocardial uptake using the Qualification Visual Score for Hypermetabolism (QVSH), evaluation of uptake patterns, standardized uptake values (SUV), and myocardial suppression levels. Additionally, time-activity curves will be utilized to analyze perfusion characteristics. The study is expected to be conducted between February 2026 and February 2027.

The experimental agent is [68Ga]Ga-Pentixafor, provided as a solution for injection. This radiopharmaceutical is administered via intravenous administration at a dosage of 200 MBq/kg.

The primary efficacy assessment involves determining the sensitivity and specificity of 68Ga-Pentixafor PET/CT in patients with suspected cardiac sarcoidosis. 18F-FDG PET/CT serves as the reference test for this comparison.

Secondary endpoints include the evaluation of 68Ga-Pentixafor myocardial uptake using the Qualification Visual Score for Hypermetabolism (QVSH). In instances of abnormal uptake, the pattern, extent, and anatomical location within the left and right ventricle are characterized. The uptake pattern is categorized as no uptake, diffuse uptake, focal uptake, or focal on diffuse uptake. For focal or focal on diffuse patterns, location is assessed via a validated LV segmental scoring system. Quantitative assessment of tracer uptake is performed using standardized uptake values (SUV). Myocardial suppression is scored ranging from fully suppressed to high diffuse. Additionally, the presence of uptake in other organs is recorded. Time-activity curves are utilized to evaluate the perfusion characteristics of the tracer. Image analysis is performed by two experienced observers to compare findings.