Objective The preoperative differentiation of clear cell renal cell carcinoma (ccRCC) from other renal masses remains challenging. Carbonic anhydrase IX (CAIX) is a highly specific target for noninvasive ccRCC imaging. We conducted a systematic review and meta-analysis to determine the diagnostic accuracy of CAIX-targeted PET/computed tomography (CT) for differentiating ccRCC from non-ccRCC renal masses. Methods A comprehensive search of PubMed, Embase, Scopus, and Registers (up to 30 September 2025) was supplemented by a bibliographic review. Studies evaluating CAIX-PET/CT against histopathologically were included. Of 528 records, five studies ( n = 544 patients) were included. Pooled sensitivity and specificity were synthesized using a univariate fixed-effects model; predictive values, likelihood ratios, and diagnostic odds ratio were also calculated. Results For the detection of histopathologically confirmed ccRCC (vs. non-ccRCC renal masses), the pooled sensitivity was 85.5% [95% confidence interval (CI): 81.6–88.7] and specificity of 86.5 (95% CI: 80.4–90.9). The hierarchical summary receiver operating characteristic model yielded an area under the curve of 0.894. Exploratory subgroup analysis suggested a potential difference in diagnostic performance between the tracer subtypes. Conclusion This review provides low-certainty evidence that CAIX-targeted PET/CT is a highly accurate, noninvasive tool for differentiating ccRCC from non-ccRCC renal masses in presurgical populations. Clinically, its high positive predictive value (94.6%) strongly ‘rules in’ disease, while its modest negative predictive value (~69%) limits its ability to ‘rule out’ malignancy. Further studies are warranted to validate these findings in broader clinical cohorts and for small-molecule agents.
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Emerson et al. (2026) studied this question.
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