This review aims to summarize and critically evaluate published clinical trials investigating the role of [18F]FDG PET in bladder cancer (BC) management, and to provide an overview of ongoing trials in this field.
A literature search was conducted in PubMed up to 31 August 2025 and on ClinicalTrials.gov to identify clinical trials assessing the role of [18F]FDG PET/CT in patients with BC. The search strategy used the terms "FDG PET," "bladder cancer," "PET/CT," "clinical trials," and "PET/MRI." Review articles, editorials, letters, comments, and case reports were excluded. Two investigators independently screened the literature, and additional trial information was retrieved from ClinicalTrials.gov.
Five eligible full-text publications and eight registered clinical trials were identified. Among the publications, two reported study protocols, two were pilot studies, and one was an ancillary analysis from a larger trial. In addition, eight ongoing clinical trials were retrieved from ClinicalTrials.gov. Available data suggest that [18F]FDG PET/MRI may be more suitable than PET/CT for evaluating primary bladder lesions, while PET/CT is particularly effective in detecting distant metastases. Several ongoing studies are also investigating delayed acquisition protocols to improve detection of nodal metastases.
[18F]FDG PET/CT and PET/MRI show promise for enhancing local and distant staging in muscle-invasive bladder cancer, although their role in nodal evaluation remains uncertain. Current evidence is limited by heterogeneous study designs, small patient cohorts, and the lack of standardized imaging protocols.
The quarterly journal of nuclear medicine and molecular imaging : official publication of the Italian Association of Nuclear Medicine (AIMN) [and] the International Association of Radiopharmacology (IAR), [and] Section of the Society of.... 2026 Jun [Epub]
Priscilla Guglielmo, Elisabetta Perrone, Pınar P Özcan, Paola Mapelli, Angelo Porreca, Esra Arslan, Laura Evangelista
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy., Unit of Nuclear Medicine, Department of Diagnostic Imaging and Radiation Oncology, IRCCS A. Gemelli University Polyclinic Foundation, Rome, Italy., Department of Nuclear Medicine, Mersin University, Mersin, Türkiye., Faculty of Medicine and Surgery, Vita-Salute San Raffaele University, Milan, Italy., Clinic of Nuclear Medicine, University of Health and Sciences Türkiye, Istanbul Training and Research Hospital, Istanbul, Türkiye., Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy - .