Pharmaceuticals (Nov 2024)

[68Ga]Ga-FAPI-46 PET/CT for Staging Suspected/Confirmed Lung Cancer: Results on the Surgical Cohort Within a Monocentric Prospective Trial

  • Lucia Zanoni,
  • Emilia Fortunati,
  • Giulia Cuzzani,
  • Claudio Malizia,
  • Filippo Lodi,
  • Veronica Serena Cabitza,
  • Irene Brusa,
  • Stefano Emiliani,
  • Marta Assenza,
  • Filippo Antonacci,
  • Francesca Giunchi,
  • Alessio Degiovanni,
  • Marco Ferrari,
  • Filippo Natali,
  • Thomas Galasso,
  • Gian Piero Bandelli,
  • Simona Civollani,
  • Piero Candoli,
  • Antonietta D’Errico,
  • Piergiorgio Solli,
  • Stefano Fanti,
  • Cristina Nanni

DOI
https://doi.org/10.3390/ph17111468
Journal volume & issue
Vol. 17, no. 11
p. 1468

Abstract

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Background/Objectives. To evaluate T&N-staging diagnostic performance of [68Ga]Ga-FAPI-46 PET/CT (FAPI) in a suspected/confirmed lung cancer surgical cohort. Methods: Patients were enrolled in a prospective monocentric trial (EudraCT: 2021-006570-23) to perform FAPI, in addition to conventional-staging-flow-chart (including [18F]F-FDG PET/CT-FDG). For the current purpose, only surgical patients were included. PET-semiquantitative parameters were measured for T&N: SUVmax, target-to-background-ratios (using mediastinal blood pool-MBP, liver-L and pulmonary-parenchyma-P). Visual and semiquantitative T&N PET/CT performances were analysed per patient and per region for both tracers, with surgical histopathology as standard-of-truth. Results: 63 FAPI scans were performed in 64 patients enrolled (26 May 2022–30 November 2023). A total of 50/63 patients underwent surgery and were included. Agreement (%) with histopathological-T&N-StagingAJCC8thEdition was slightly in favour of FAPI (T-66% vs. 58%, N-78% vs. 70%), increasing when T&N dichotomised (T-92% vs. 80%, N-78% vs. 72%). The performance of Visual-Criteria for T-per patient (n = 50) resulted higher FAPI than FDG. For N-per patient (n = 46), sensitivity and NPV were slightly lower with FAPI. Among 59 T-regions surgically examined, malignancy was excluded in 6/59 (10%). FAPI showed (vs. FDG): sensitivity 85% (vs. 72%), specificity 67% (vs. 50%), PPV 96% (vs. 93%), NPV 33% (vs. 17%), accuracy 83% (vs. 69%). Among 217 N-stations surgically assessed (overall 746 ln removed), only 15/217 (7%) resulted malignant; FAPI showed (vs. FDG): sensitivity 53% (vs. 60%), PPV 53% (vs. 26%), NPV 97% (vs. 97%), and significantly higher specificity (97% vs. 88%, p = 0.001) and accuracy (94% vs. 86%, p = 0.018). Semiquantitative-PET parameters performed similarly, better for N (p < 0.001) than for T, slightly in favour (although not significantly) of FAPI over FDG. Conclusions: In a suspected/confirmed lung cancer surgical cohort, PET/CT performances for preoperative T&Nstaging were slightly in favour of FAPI than FDG (except for suboptimal N-sensitivity), significantly better only for N (region-based) specificity and accuracy using visual assessment. The trial’s conventional follow-up is still ongoing; future analyses are pending, including non-surgical findings and theoretical impact on patient management.

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