Trial reportEuropean journal of nuclear medicine and molecular imaging2026
CAIX-targeted PET/CT in the evaluation of clear cell renal cell carcinoma: a head-to-head comparison with [
Trial report in European journal of nuclear medicine and molecular imaging, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
purposeTo evaluate the diagnostic performance and staging of the novel CAIX-targeted tracer [18F]AlF-NYM005 in clear cell renal cell carcinoma (ccRCC), and directly compare it with that of [18F]FDG PET/CT.
methodsThis prospective single-center trial enrolled 61 patients (41 male, 20 female; median age, 62.0 years). Participants underwent [18F]AlF-NYM005 and [18F]FDG PET/CT within one week. A composite reference standard including histopathology, follow-up, or multimodal imaging was used to define 331 lesions (35 renal, 296 metastatic). Diagnostic performance, standardized uptake value (SUV) and tumour-node-metastasis (TNM) classifications were evaluated and compared between the two tracers.
resultsFor renal tumours, [18F]AlF-NYM005 PET/CT demonstrated significantly superior diagnostic performance to [18F]FDG (P < 0.001), with higher sensitivity (82.1% vs. 42.9%), specificity (85.7% vs. 42.9%), positive predictive value (95.8% vs. 75.0%), negative predictive value (54.5% vs. 15.8%), and accuracy (82.9% vs. 42.9%). In metastatic lesions, [18F]AlF-NYM005 detected significantly more lesions (248 vs. 156, P < 0.001), particularly in lymph nodes, pleura/peritoneum, and lung. Compared with [18F]FDG, [18F]AlF-NYM005 PET/CT consequently altered the staging/restaging of approximately one-third of patients. Quantitative analysis demonstrated higher tumour uptake (SUVmax) with [18F]AlF-NYM005 in renal tumours (11.8 vs. 3.5) and metastatic lesions (5.0 vs. 3.2), along with a higher tumour-to-liver ratio (3.9 vs. 1.6). Immunohistochemistry showed that 66.7% of samples had intermediate/strong CAIX expression, which was positively correlated with [18F]AlF-NYM005 uptake, pT stage, and WHO/ISUP grade.
conclusion[18F]AlF-NYM005 PET/CT was superior to [18F]FDG in the detection of renal tumours and metastatic lesions, demonstrating higher radiotracer uptake and more accurate staging.
trial registrationChinese Clinical Trial Registry. ChiCTR2400085765, Registered 18 June 2024, retrospectively registered.
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