68Ga-NY104 PET/CT Outperforms 18F-FDG PET/CT in Metastatic ccRCC

Source: GU Oncology Now
URL: https://www.guoncologynow.com/post/68ga-ny104-pet-ct-outperforms-18f-fdg-pet-ct-in-metastatic-ccrcc

68Ga-NY104 PET/CT demonstrates superior diagnostic performance compared to 18F-FDG PET/CT in metastatic clear cell renal cell carcinoma (ccRCC), with 96.6% sensitivity and 99.1% specificity versus 77.8% and 5.5% respectively. This carbonic anhydrase IX (CAIX)-targeted imaging agent offers significantly improved lesion detection and characterization in metastatic ccRCC patients.

Study Design & Population

  • Prospective, single-center, single-arm phase II study (NCT05879471)
  • 44 patients with metastatic ccRCC (mean age 59.6 ± 10.7 years, 91% male)
  • 677 lesions identified across 172 anatomical regions
  • Both imaging modalities performed within 1 week, with tyrosine kinase inhibitors discontinued ≥1 week prior

Key Findings

  • Lesion-level performance: 68Ga-NY104 sensitivity 96.6% vs 18F-FDG 77.8% (P<.001); specificity 99.1% vs 5.5% (P<.001)
  • Region-level performance: 68Ga-NY104 sensitivity 98.4% vs 18F-FDG 82.0% (P<.001); specificity 97.7% vs 11.4% (P<.001)
  • SUVmax values: 68Ga-NY104 showed higher uptake in ccRCC lesions (12.6 ± 11.7 vs 7.5 ± 10.5, P<.001)
  • Tumor-to-background ratio: Superior contrast with 68Ga-NY104 (15.7 ± 14.6 vs 4.8 ± 5.5, P<.001)

Clinical Implications

  • 68Ga-NY104 PET/CT may become preferred imaging modality for metastatic ccRCC staging and surveillance
  • Superior specificity could reduce false-positive findings and unnecessary interventions
  • CAIX-targeted imaging provides better differentiation between ccRCC and non-ccRCC lesions

Limitations

  • Single-center study with relatively small sample size (n=44)
  • Single-arm design without randomized comparison
  • Requires validation in larger multicenter trials before clinical implementation
  • Cost-effectiveness compared to standard imaging not evaluated

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