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Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/223379
Imaging Efficacy of [18F]CTT1057 PET for the Detection of PSMA-Positive Tumors Using Histopathology as Standard of Truth: Results from the GuideView Phase 2/3 Prospective Multicenter Study
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[18F]CTT1057 is a highly selective prostate-specific membrane antigen (PSMA)-targeted PET radiotracer for prostate cancer (PCa) detection. This prospective study (GuideView, NCT04838626) evaluates the imaging efficacy of [18F]CTT1057 PET to detect PSMA-positive lesions against histopathology in patients with newly diagnosed, untreated, high-risk PCa. Methods: Between September 7, 2021, and October 26, 2023, 201 patients planned for radical prostatectomy were screened and 195 patients were enrolled. Of these, 184 patients received a median of 355 MBq (range, 195-400 MBq) of [18F]CTT1057 and underwent PET/CT 90 min (±30 min) later. Three masked central independent readers evaluated the images. Coprimary endpoints were patient-level sensitivity (including primary tumor and pelvic lymph nodes) and region-level specificity (including pelvic lymph nodes only) for detection of PSMA-positive lesions, using histopathology as the standard of truth. The lower-bound 95% CI needed to surpass 50% for patient-level sensitivity and 70% for region-level specificity. Success was defined as at least 2 of 3 central readers meeting these criteria. Secondary endpoints included the patient-level and region-level positive predictive value and accuracy, region-level sensitivity, inter- and intrareader variability, detection rate of distant metastasis, pharmacokinetics, and safety and tolerability assessments. Results: Of the 184 patients who received [18F]CTT1057, 172 patients were evaluable for efficacy. Among these, a median of 19 lymph nodes (interquartile range, 13.0-28.5 lymph nodes) were dissected per patient. Both coprimary endpoints were met, with lower bounds of 95% CIs surpassing the success criteria for all 3 readers for both patient-level sensitivity (range, 86.8%-90.0%; lower-bound 95% CI, 80.7%-84.5%) and region-level specificity (97.1%; lower-bound 95% CI, 92.7%). Interreader variability Fleiss κ was 63.9%; intrareader reproducibility Cohen κ was 89.4%-100%. [18F]CTT1057 had a favorable safety profile. Conclusion: GuideView confirmed the imaging efficacy of [18F]CTT1057 for the detection of PSMA-positive lesions, with high patient-level sensitivity and region-level specificity. Substantial interreader variability and almost perfect intrareader reproducibility suggest that [18F]CTT1057 findings are robust and reliable. [18F]CTT1057 will contribute to expanding access to PSMA PET imaging to properly diagnose and treat patients with PCa.
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IAGARU, Andrei, SUÁREZ-NOVO, José francisco, BEHR, Spencer, AGGARWAL, Rahul, PAREDES BARRANCO, Pilar, BUFFI, Nicolo, PENHOAT, Thomas, CECI, Francesco, WALZ, Jochen, DOUMERC, Nicolas, COULANGES, Medge, XU, Zhongying, SEIGNE, Christelle, WILKE, Celine, CATAFAU, Ana m., FANTI, Stefano, MAURER, Tobias. Imaging Efficacy of [18F]CTT1057 PET for the Detection of PSMA-Positive Tumors Using Histopathology as Standard of Truth: Results from the GuideView Phase 2/3 Prospective Multicenter Study. _Journal of Nuclear Medicine_. 2025. Vol. 66, núm. 8, pàgs. 1232-1238. [consulta: 26 de novembre de 2025]. ISSN: 0161-5505. [Disponible a: https://hdl.handle.net/2445/223379]