Evaluation of an Automated Module Synthesis and a Sterile Cold Kit–Based Preparation of <sup>68</sup>Ga-PSMA-11 in Patients with Prostate Cancer

Calderoni, Letizia; Farolfi, Andrea; Pianori, Davide; Maietti, Elisa; Cabitza, Veronica; Lambertini, Alessandro; Ricci, G; Telo, Silvi; Lodi, Filippo; Castellucci, Paolo; Fanti, Stefano

doi:10.2967/jnumed.119.231605

Cited by 21 publications

(18 citation statements)

References 18 publications

(14 reference statements)

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“…68 Ga was obtained after elution from a 68 Ge/ 68 Ga radionuclide generator (Gali-Eo; IRE, Belgium) and used for radiolabeling after 5 min of incubation at room temperature by using a sterile cold kit GMP vial containing 25 µg of lyophilized precursor PSMA-11 (Telix Pharmaceuticals Ldt., Melbourne, Australia) following the manufacturer’s recommendations as previously published [ 50 ]. Quality control was performed using thin-layer chromatography showing a radiochemical purity of >99%, and sterility and pyrogen content were tested according to European Pharmacopoeia methods.…”

Section: Methodsmentioning

confidence: 99%

Oligometastatic Disease Detection with 68Ga-PSMA-11 PET/CT in Hormone-Sensitive Prostate Cancer Patients (HSPC) with Biochemical Recurrence after Radical Prostatectomy: Predictive Factors and Clinical Impact

Artigas

Diamand

Shagera

et al. 2021

Cancers

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Metastasis-directed therapy (MDT) in oligometastatic prostate cancer has the potential of delaying the start of androgen deprivation therapy (ADT) and disease progression. We aimed to analyze the efficacy of PSMA-PET/CT in detecting oligometastatic disease (OMD), to look for predictive factors of OMD, and to evaluate the impact of PSMA-PET/CT findings on clinical management. We retrospectively analyzed a homogeneous population of 196 hormone-sensitive prostate cancer patients (HSPC), considered potential candidates for MDT, with a PSMA-PET/CT performed at biochemical recurrence (BCR) after radical prostatectomy (RP). Multivariable logistic regression analysis was performed based on several clinico-pathological factors. Changes in clinical management before and after PSMA-PET/CT were analyzed. The OMD detection rate was 44% for a total positivity rate of 60%. PSMA-PET/CT positivity was independently related to PSA (OR (95%CI), p) (1.7 (1.3–2.3), p < 0.0001) and PSAdt (0.4 (0.2–0.8), p = 0.013), and OMD detection was independently related to PSA (1.6 (1.2–2.2), p = 0.001) and no previous salvage therapy (0.3 (0.1–0.9), p = 0.038). A treatment change was observed in 58% of patients, mostly to perform MDT after OMD detection (60% of changes). This study showed that PSMA-PET/CT is an excellent imaging technique to detect OMD early in HSPC patients with BCR after RP, changing therapeutic management mostly into MDT.

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Section: Methodsmentioning

confidence: 99%

Oligometastatic Disease Detection with 68Ga-PSMA-11 PET/CT in Hormone-Sensitive Prostate Cancer Patients (HSPC) with Biochemical Recurrence after Radical Prostatectomy: Predictive Factors and Clinical Impact

Artigas

Diamand

Shagera

et al. 2021

Cancers

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“…Both kits can be used with the commercially available and authorized 68 Ge/ 68 Ga generators. Using the cold kit TLX591-CDx, 68 Ga has to be eluted first into a separate sterile vial before the addition of the dissolved labeling precursor and reaction for 5 min at room temperature [ 44 ]. While the kit by Telix Pharmaceuticals consists of three vials, the kit by Isotopia consists of only one vial, further facilitating the convenient synthesis [ 45 ].…”

Section: Chemical Overviewmentioning

confidence: 99%

“…Using the isoPROtrace-11 kit, [ 68 Ga]Ga-PSMA-11 can be prepared by just adding the 68 Ga eluate to a sterile kit vial containing the lyophilized labeling precursor and reacting for 5 min at room temperature. The quality of the product has been validated for both cold kit preparations, and its clinical applicability has been demonstrated [ 44 , 46 ]. One drawback of the kit preparations is that they have not yet been approved by international authorities and can only be used in investigational studies.…”

Section: Chemical Overviewmentioning

confidence: 99%

[68Ga]Ga-PSMA-11: The First FDA-Approved 68Ga-Radiopharmaceutical for PET Imaging of Prostate Cancer

Hennrich

Eder

2021

Pharmaceuticals

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For the positron emission tomography (PET) imaging of prostate cancer, radiotracers targeting the prostate-specific membrane antigen (PSMA) are nowadays used in clinical practice. Almost 10 years after its discovery, [68Ga]Ga-PSMA-11 has been approved in the United States by the Food and Drug Administration (FDA) as the first 68Ga-radiopharmaceutical for the PET imaging of PSMA-positive prostate cancer in 2020. This radiopharmaceutical combines the peptidomimetic Glu-NH-CO-NH-Lys(Ahx)-HBED-CC with the radionuclide 68Ga, enabling specific imaging of tumor cells expressing PSMA. Such a targeting approach may also be used for therapy planning as well as potentially for the evaluation of treatment response.

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“…The second method is the use of a vial kit for the preparation of gallium-68 labeled peptides that is currently used at the Department of Nuclear Medicine, University of Pretoria, South Africa. 9 Although literature is available describing both kit vial and automated synthesis methods for [ 68 Ga]Ga-PSMA-11 synthesis in the same facility, [11][12][13][14] to our knowledge, no in-depth discussion of the radiation protection, departmental logistics, and complete outcome of synthesis parameters exists. A recent investigation by Meisenheimer et al only compared manual labeling (not kit-based labeling) and automated synthesis based on reliability and reproducibility without taking into account additional important considerations like radiation exposure or pharmaceutical quality of the final product.…”

Section: Introductionmentioning

confidence: 99%

Production of [⁶⁸Ga]Ga‐PSMA: Comparing a manual kit‐based method with a module‐based automated synthesis approach

Kleynhans

Rubow

et al. 2020

Labelled Comp Radiopharmac

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The labeling of peptides with gallium-68 is often initially performed by manual labeling, but with high clinical demand, other alternatives are needed. Coldkits or automated synthesis are viable options for standardized methods and deemed pharmaceutically more acceptable. This study compares these [ 68 Ga] Ga-PSMA-11 production methods. Data from 40 kit-based and 40 automated syntheses of [ 68 Ga]Ga-PSMA-11 were analyzed. Pre-set criteria were evaluated including radiochemical purity, radionuclidic purity, chemical purity, physiological acceptability and sterility. The operator time and radiation dose received were measured. The robustness and repeatability of each method were assessed and a comparison of the running costs of each method is also provided. For both the methods all the analyzed products met the release criteria. No differences were found in radiochemical purity, radiochemical identity, radionuclidic purity, and sterility. However, radiochemical yield and apparent molar activity showed significant differences. For both methods, whole body radiation exposure to operators was lower than with manual labeling (25-40 μSv). The exposure during kit-based labeling (14.5 ± μSv) was seven times higher than that of automated synthesis (2.05 ± 0.99 μSv). The automated synthesis was the more expensive method. Both methods are sound alternatives to manual synthesis and offer higher quality, better radiation protection and a more reliable manufacturing of radiopharmaceuticals.

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Evaluation of an Automated Module Synthesis and a Sterile Cold Kit–Based Preparation of ⁶⁸Ga-PSMA-11 in Patients with Prostate Cancer

Cited by 21 publications

References 18 publications

Oligometastatic Disease Detection with 68Ga-PSMA-11 PET/CT in Hormone-Sensitive Prostate Cancer Patients (HSPC) with Biochemical Recurrence after Radical Prostatectomy: Predictive Factors and Clinical Impact

Oligometastatic Disease Detection with 68Ga-PSMA-11 PET/CT in Hormone-Sensitive Prostate Cancer Patients (HSPC) with Biochemical Recurrence after Radical Prostatectomy: Predictive Factors and Clinical Impact

[68Ga]Ga-PSMA-11: The First FDA-Approved 68Ga-Radiopharmaceutical for PET Imaging of Prostate Cancer

Production of [⁶⁸Ga]Ga‐PSMA: Comparing a manual kit‐based method with a module‐based automated synthesis approach

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Evaluation of an Automated Module Synthesis and a Sterile Cold Kit–Based Preparation of 68Ga-PSMA-11 in Patients with Prostate Cancer

Cited by 21 publications

References 18 publications

Oligometastatic Disease Detection with 68Ga-PSMA-11 PET/CT in Hormone-Sensitive Prostate Cancer Patients (HSPC) with Biochemical Recurrence after Radical Prostatectomy: Predictive Factors and Clinical Impact

Oligometastatic Disease Detection with 68Ga-PSMA-11 PET/CT in Hormone-Sensitive Prostate Cancer Patients (HSPC) with Biochemical Recurrence after Radical Prostatectomy: Predictive Factors and Clinical Impact

[68Ga]Ga-PSMA-11: The First FDA-Approved 68Ga-Radiopharmaceutical for PET Imaging of Prostate Cancer

Production of [68Ga]Ga‐PSMA: Comparing a manual kit‐based method with a module‐based automated synthesis approach

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Evaluation of an Automated Module Synthesis and a Sterile Cold Kit–Based Preparation of ⁶⁸Ga-PSMA-11 in Patients with Prostate Cancer

Production of [⁶⁸Ga]Ga‐PSMA: Comparing a manual kit‐based method with a module‐based automated synthesis approach