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Purpose <p>To evaluate the diagnostic performance and staging of the novel CAIX-targeted tracer [<sup>18</sup>F]AlF-NYM005 in clear cell renal cell carcinoma (ccRCC), and directly compare it with that of [<sup>18</sup>F]FDG PET/CT.</p> Methods <p>This prospective single-center trial enrolled 61 patients (41 male, 20 female; median age, 62.0 years). Participants underwent [<sup>18</sup>F]AlF-NYM005 and [<sup>18</sup>F]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.</p> Results <p>For renal tumours, [<sup>18</sup>F]AlF-NYM005 PET/CT demonstrated significantly superior diagnostic performance to [<sup>18</sup>F]FDG (<i>P</i> &lt; 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, [<sup>18</sup>F]AlF-NYM005 detected significantly more lesions (248 vs. 156, <i>P</i> &lt; 0.001), particularly in lymph nodes, pleura/peritoneum, and lung. Compared with [<sup>18</sup>F]FDG, [<sup>18</sup>F]AlF-NYM005 PET/CT consequently altered the staging/restaging of approximately one-third of patients. Quantitative analysis demonstrated higher tumour uptake (SUVmax) with [<sup>18</sup>F]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 [<sup>18</sup>F]AlF-NYM005 uptake, pT stage, and WHO/ISUP grade.</p> Conclusion <p>[<sup>18</sup>F]AlF-NYM005 PET/CT was superior to [<sup>18</sup>F]FDG in the detection of renal tumours and metastatic lesions, demonstrating higher radiotracer uptake and more accurate staging.</p> Trial registration <p>Chinese Clinical Trial Registry. ChiCTR2400085765, Registered 18 June 2024, retrospectively registered.</p>

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CAIX-targeted PET/CT in the evaluation of clear cell renal cell carcinoma: a head-to-head comparison with [18F]FDG PET/CT

  • 期刊论文

  • 发表日期：

    2026年2月3日

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  • Wei Guo,
  • Liang Cheng,
  • Xinglu Zhou,
  • Yue Zhao,
  • Hui Chen,
  • Yubai Zhang,
  • Yudie Qin,
  • Wei Liu,
  • Geng Hu,
  • Xinyue Yang,
  • Huihui You,
  • Wenyi Wei,
  • Dayong Hou,
  • Hao Jiang,
  • Kezheng Wang

摘要

Purpose

To 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.

Methods

This 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.

Results

For 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 registration

Chinese Clinical Trial Registry. ChiCTR2400085765, Registered 18 June 2024, retrospectively registered.