Fine‐tuning of the automated [<sup>18</sup>F]PSMA‐1007 radiosynthesis

Shamni, Ofer; Nebeling, B.; Grievink, Hilbert; Mishani, Eyal

doi:10.1002/jlcr.3732

Cited by 10 publications

(10 citation statements)

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“…18 F-PSMA-1007. The 18 F-PSMA-1007 was synthesized by a fully automated process as was previously described (22). In brief, after trapping the ( 18 F)/H 2 18 O from the target, it was loaded onto an anion exchange column (30PS-HCO3; Macherey Nagel), eluted using 0.65 mL of thiobarbituric acid solution (0.075 M; ABX GmBH), and transferred to the reactor followed by addition of 1.5 mL of acetonitrile (Across Organics) and azeotropic removal of water.…”

mentioning

confidence: 99%

Head-to-Head Comparison of ⁶⁸Ga-PSMA-11 with ¹⁸F-PSMA-1007 PET/CT in Staging Prostate Cancer Using Histopathology and Immunohistochemical Analysis as a Reference Standard

et al. 2019

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18 F-PSMA-1007 is a novel prostate-specific membrane antigen (PSMA)-based radiopharmaceutical for imaging prostate cancer (PCa). The aim of this study was to compare the diagnostic accuracy of 18 F-PSMA-1007 with 68 Ga-PSMA-11 PET/CT in the same patients presenting with newly diagnosed intermediate-or high-risk PCa. Methods: Sixteen patients with intermediate-or high-risk PCa underwent 18 F-PSMA-1007 and 68 Ga-PSMA-11 PET/CT within 15 d. PET findings were compared between the 2 radiotracers and with reference-standard pathologic specimens obtained from radical prostatectomy. The Cohen κ-coefficient was used to assess the concordance between 18 F-PSMA-1007 and 68 Ga-PSMA-11 for detection of intraprostatic lesions. The McNemar test was used to assess agreement between intraprostatic PET/CT findings and histopathologic findings. Sensitivity, specificity, positive predictive value, and negative predictive value were reported for each radiotracer. SUV max was measured for all lesions, and tumor-to-background activity was calculated. Areas under receiver-operating-characteristic curves were calculated for discriminating diseased from nondiseased prostate segments, and optimal SUV cutoffs were calculated using the Youden index for each radiotracer. Results: PSMA-avid lesions in the prostate were identified in all 16 patients with an almost perfect concordance between the 2 tracers (κ ranged from 0.871 to 1). Aside from the dominant intraprostatic lesion, similarly detected by both radiotracers, a second less intense positive focus was detected in 4 patients only with 18 F-PSMA-1007. Three of these secondary foci were confirmed as Gleason grade 3 lesions, whereas the fourth was shown on pathologic examination to represent chronic prostatitis. Conclusion: This pilot study showed that both 18 F-PSMA-1007 and 68 Ga-PSMA-11 identify all dominant prostatic lesions in patients with intermediateor high-risk PCa at staging. 18 F-PSMA-1007, however, may detect additional low-grade lesions of limited clinical relevance.

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confidence: 99%

Head-to-Head Comparison of ⁶⁸Ga-PSMA-11 with ¹⁸F-PSMA-1007 PET/CT in Staging Prostate Cancer Using Histopathology and Immunohistochemical Analysis as a Reference Standard

et al. 2019

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“…Radiosynthesis of [ 18 F]-PSMA-1007 were performed using a fully automated radiosynthesizer (AllInOne 36, Trasis, Belgium; with 36 manifold actuators and a disposable uid pathway) as was previously described (Shammi O., et al 2019). The use of disposable cassettes ensures clean and reproducible operations throughout the whole radiolabeling.…”

Section: Methodsmentioning

confidence: 99%

“…For each radiosynthesis a large amount of [ 18 F]-labeled PSMA may be produced, enabling to study a higher number of patients than those with of [ 68 Ga]-PSMA. The [ 18 F] physical half-life (T 1/2 = 109') and larger productions by cyclotron might allow also to provide the distribution to several PET centers distant not more than 4-hours from the producing cyclotron/radiopharmacy facility (Shammi O., et al 2019). Preliminary clinical reports indicated that uorinated PSMA offers other, additional, advantages: higher tumor-to-background ratios (Kesch C. et al, 2017) and low renal excretion (Giesel FL, et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

On Site Production of [18F]-PSMA1007 Using Different [18F]-fluoride Activities. Practical, Technical and Economical Impact.

Maisto

Morisco

Marino

et al. 2021

Preprint

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BackgroundProstate-Specific Membrane Antigen is overexpressed in prostate cancer and it is considered a good target for staging of primary and recurrences as well as for radioligand therapy. Different PSMA-analogues have been investigated, labeled with [68Ga], showing excellent imaging properties; although, only small amounts can be produced for single synthesis. Recently, a fluorinated PSMA-inhibitor, [18F]-PSMA-1007, has been introduced, ensuring large-scale productions. In this study, the radiosynthesis of [18F]-PSMA-1007 using low (A), medium (B) and high (C) starting activities of [18F]-Fluoride, has been fully tested. The following parameters radiochemical yield, radiochemical purity and stability of [18F]-PSMA-1007 have been measured in 65, consecutive batches to verify the effects of the three different conditions. In addition, the analysis of the costs for the production has been performed. ResultsThe radiochemical yield percentage for low and medium range of activities of [18F]-Fluoride was 52%, while for the high range it decreases to 40%. The radiochemical purity was 99% in all three tested starting activities. [18F]-PSMA-1007 did not show radiolysis up to 8 hours after the end of synthesis, confirming that the radiopharmaceutical is stable an suitable for PET studies in humans. Furthermore, stability studies performed in fetal bovine serum demonstrated radiochemical stability at 37°C for 120’. ConclusionsA starting activity of [18F]-Fluoride of 90 GBq (range B) enables a final amount of [18F]-PSMA-1007 of about 50 GBq, which is powerful for different choices: to perform up to 25 PET/CT scans in a referral institution for prostate cancer, and/or to supply the eventual peripheral PET centers.

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“…The automated, one-step synthesis of [ 18 F]PSMA-1007 was carried out as previously reported (15). Mean radiochemical purity at the end of synthesis was 96.2 ± 1.6% (range 94.1%-99.4%), with no detectable 18 F-fluoride in 13/14 syntheses and 1.1% 18 F − in one synthesis.…”

Section: Radiosynthesismentioning

confidence: 99%

False Positive Findings of [18F]PSMA-1007 PET/CT in Patients After Radical Prostatectomy with Undetectable Serum PSA Levels

et al. 2022

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BackgroundPET-CT using prostate-specific membrane antigen (PSMA)-targeting radiopharmaceuticals labeled with 68Ga or 18F has emerged as the most sensitive staging tool in prostate cancer (PC). Nonetheless, the occurrence of false positive (FP) findings presents a major concern of this approach. In this prospective study, we investigated the frequency and pattern of false-positive findings of [18F]PSMA-1007 PET/CT in patients after radical prostatectomy with undetectable serum PSA levels. Any discrete non-physiological accumulation of [18F]PSMA-1007 in this population is by definition FP.MethodsSeventeen men after radical prostatectomy, whose serum PSA levels were <0.05 ng/mL at 2–24 months after surgery were prospectively recruited. PET/CT was acquired at both 1 and 2 h after injection of [18F]PSMA-1007.FindingsThree studies (18%) were interpreted as completely normal. Thirty-five foci of “non-physiological” uptake were observed in the remaining 14 (82%) patients, including a single skeletal focus in four patients, multiple skeletal foci in five patients and soft tissue uptake in eight, including in a desmoid tumor and in pelvic lymphocele. The SUVmax of all lesions was in the range of 1–7, except for the desmoid tumor which measured 12.7. All foci were visible in both the 1- and the 2 h studies, presenting a minor (<10%), statistically insignificant increase of SUVmax during this time-interval.InterpretationFP [18F]PSMA-1007-avid foci are found in about 80% of patients with undetectable serum PSA levels. Thus, focal uptake of [18F]PSMA-1007 outside its physiological distribution is not a categorical sign of metastasis and can arise from non-specific uptake of the ligand. The interpretation of [18F]PSMA-1007 PET/CT studies should always consider the clinical context, and lesions with SUVmax < 7 are suspicious for FP.

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Fine‐tuning of the automated [¹⁸F]PSMA‐1007 radiosynthesis

Cited by 10 publications

References 18 publications

Head-to-Head Comparison of ⁶⁸Ga-PSMA-11 with ¹⁸F-PSMA-1007 PET/CT in Staging Prostate Cancer Using Histopathology and Immunohistochemical Analysis as a Reference Standard

Head-to-Head Comparison of ⁶⁸Ga-PSMA-11 with ¹⁸F-PSMA-1007 PET/CT in Staging Prostate Cancer Using Histopathology and Immunohistochemical Analysis as a Reference Standard

On Site Production of [18F]-PSMA1007 Using Different [18F]-fluoride Activities. Practical, Technical and Economical Impact.

False Positive Findings of [18F]PSMA-1007 PET/CT in Patients After Radical Prostatectomy with Undetectable Serum PSA Levels

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Fine‐tuning of the automated [18F]PSMA‐1007 radiosynthesis

Cited by 10 publications

References 18 publications

Head-to-Head Comparison of 68Ga-PSMA-11 with 18F-PSMA-1007 PET/CT in Staging Prostate Cancer Using Histopathology and Immunohistochemical Analysis as a Reference Standard

Head-to-Head Comparison of 68Ga-PSMA-11 with 18F-PSMA-1007 PET/CT in Staging Prostate Cancer Using Histopathology and Immunohistochemical Analysis as a Reference Standard

On Site Production of [18F]-PSMA1007 Using Different [18F]-fluoride Activities. Practical, Technical and Economical Impact.

False Positive Findings of [18F]PSMA-1007 PET/CT in Patients After Radical Prostatectomy with Undetectable Serum PSA Levels

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Fine‐tuning of the automated [¹⁸F]PSMA‐1007 radiosynthesis

Head-to-Head Comparison of ⁶⁸Ga-PSMA-11 with ¹⁸F-PSMA-1007 PET/CT in Staging Prostate Cancer Using Histopathology and Immunohistochemical Analysis as a Reference Standard

Head-to-Head Comparison of ⁶⁸Ga-PSMA-11 with ¹⁸F-PSMA-1007 PET/CT in Staging Prostate Cancer Using Histopathology and Immunohistochemical Analysis as a Reference Standard