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000874917 1001_ $$0P:(DE-HGF)0$$aDietlein, Felix$$b0
000874917 245__ $$aAn 18 F-Labeled PSMA Ligand for PET/CT of Prostate Cancer: First-in-Humans Observational Study and Clinical Experience with 18 F-JK-PSMA-7 During the First Year of Application
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000874917 520__ $$aIn preclinical trials, the recently developed tracer 2-methoxy-18F-DCFPyL (18F-JK-prostate-specific membrane antigen [PSMA]-7) has shown favorable properties regarding clinical performance and radiochemical accessibility. The aim of this study was to evaluate the clinical utility of 18F-JK-PSMA-7 for PET/CT imaging of patients with prostate cancer. Methods: In an Institutional Review Board–approved pilot study, the initial clinical utility of PET/CT imaging with 18F-JK-PSMA-7 was directly compared with 68Ga-PSMA-11 PET/CT in a group of 10 patients with prostate cancer. The 2 PSMA tracers were administered to each patient less than 3 wk apart. Next, we analyzed the data of 75 consecutive patients who had undergone clinical 18F-JK-PSMA-7 PET/CT imaging for tumor localization of biochemical recurrence (BCR). Results: The pilot study in 10 patients who were examined with both PSMA tracers demonstrated that 18F-JK-PSMA-7 was at least equivalent to 68Ga-PSMA-11. All unequivocally 68Ga-PSMA-11–positive lesions could be also detected using 18F-JK-PSMA-7, and in 4 patients additional suspected PSMA-positive lesions were identified (1 patient changed from PSMA-negative to PSMA-positive). In patients with BCR (after prostatectomy or radiotherapy), the capacity of 18F-JK-PSMA-7 PET/CT to detect at least one PSMA-positive lesion was 84.8%. The prostate-specific antigen (PSA)–stratified detection rate of 18F-JK-PSMA-7 after prostatectomy varied among 54.5% (6/11 patients; PSA < 0.5 μg/L), 87.5% (14/16 patients; PSA 0.5–2 μg/L), and 90.9% (20/22 patients; PSA > 2 μg/L). Conclusion: The tracer 18F-JK-PSMA-7 was found to be safe and clinically useful. We demonstrated that 18F-JK-PSMA-7 was not inferior when directly compared with 68Ga-PSMA-11 in a pilot study but indeed identified additional PSMA-avid suspected lesions in oligometastasized patients with BCR. In a subsequent analysis of a clinical cohort of BCR patients, 18F-JK-PSMA-7 was useful in tumor localization. 18F-JK-PSMA-7 is recommended for future prospective trials. 
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000874917 7001_ $$0P:(DE-HGF)0$$aHohberg, Melanie$$b1
000874917 7001_ $$0P:(DE-HGF)0$$aKobe, Carsten$$b2
000874917 7001_ $$0P:(DE-Juel1)176188$$aZlatopolskiy, Boris D.$$b3$$ufzj
000874917 7001_ $$0P:(DE-Juel1)169356$$aKrapf, Philipp$$b4$$ufzj
000874917 7001_ $$0P:(DE-Juel1)180330$$aEndepols, Heike$$b5$$ufzj
000874917 7001_ $$0P:(DE-HGF)0$$aTäger, Philipp$$b6
000874917 7001_ $$0P:(DE-HGF)0$$aHammes, Jochen$$b7
000874917 7001_ $$0P:(DE-HGF)0$$aHeidenreich, Axel$$b8
000874917 7001_ $$0P:(DE-Juel1)166419$$aNeumaier, Bernd$$b9$$ufzj
000874917 7001_ $$0P:(DE-Juel1)177611$$aDrzezga, Alexander$$b10$$ufzj
000874917 7001_ $$0P:(DE-HGF)0$$aDietlein, Markus$$b11$$eCorresponding author
000874917 773__ $$0PERI:(DE-600)2040222-3$$a10.2967/jnumed.119.229542$$gVol. 61, no. 2, p. 202 - 209$$n2$$p202 - 209$$tJournal of nuclear medicine$$v61$$x2159-662X$$y2020
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