Performance and long-term consistency of five Galliform 68Ge/68Ga generators used for clinical Ga-68 preparations over a 4 year period

Sammartano, Antonino; Migliari, Silvia; Scarlattei, Maura; Baldari, Giorgio; Serreli, Giulio; Lazzara, Chiara; Garau, Ludovico; Ghetti, Caterina; Ruffini, Livia

doi:10.1097/mnm.0000000000001545

Cited by 5 publications

(31 citation statements)

References 19 publications

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“…The details of 39 patients with NET, including 27 patients confirmed by pathology in the initial evaluation and 12 evaluated after treatment, are summarized in Table 1. 18 F-FDG PET/CT accurately detected tumors in 23/27 patients at a sensitivity of 85.2%. Since other malignant tumors, such as adenocarcinoma, showed high uptake of 18 F-FDG PET/CT, leading to false positives in the enrolled patients.…”

Section: Data Availabilitymentioning

confidence: 94%

“…Then, the patient was asked to drink more water and undergo imaging 45 to 60 minutes after urination post-intravenous injection of the contrast agent. The imaging equipment and technology were the same as for 18 F-FDG PET/CT imaging.…”

Section: Ga-dotatate Pet/ct Imagingmentioning

confidence: 99%

“…The data that support these findings are available from the corresponding author upon reasonable request. 68 Ga-DOTATATE and 18 F-FDG PET/CT A total of 55 patients were evaluated by 18 F-FDG PET/CT and 68 Ga-DOTATATE PET/CT, including 43 patients with the initial evaluation and 12 with posttreatment evaluation. In the initial evaluation, 27/43 (62.8%) patients were confirmed to have neuroendocrine tumors by histological examination, including 10 females and 17 males, aged 25 to 73 (mean: 53.9 ± 11.6) years, while 16/43 (37.2%) patients could not be confirmed.…”

Section: Data Availabilitymentioning

confidence: 99%

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Comparison of the application of 18F-FDG and 68Ga-DOTATATE PET/CT in neuroendocrine tumors: A retrospective study

Wang

et al. 2023

Medicine

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The present study aimed to compare the efficacy of 68 Ga-DOTATATE PET/CT and 18 F-FDG PET/CT imaging in the diagnosis, staging, and prognosis evaluation of neuroendocrine tumors (NET). A total of 55 patients (43 were initially evaluated, 12 were evaluated after treatment) who underwent fluorine-18 labeled fluorodeoxyglucose ( 18 F-FDG) and 68 Ga DOTATE PET/CT examinations were reviewed retrospectively, and the pathological data were collected. In the initial evaluation, 27/43 were pathologically confirmed as NET patients, as detected by gallium-68 labeld 1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraaceticacid-D-Phel-Tyr3-Thr8-OC; among them, 23 were correctly detected by 18 F-FDG. In lesion-based comparison, 119/168 focal lesions were depicted on 18 F-FDG PET/CT and 68 Ga-DOTATATE PET/CT, respectively ( P = .0363). Strikingly, gallium-68 labeld 1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraaceticacid-D-Phel-Tyr3-Thr8-OC had higher maximum standard uptake value than 18 F-FDG but was negatively related to the NET grade for the former, while the latter was positively related to the NET. The value of 68 Ga-DOTATATE PET/CT in the diagnosis and staging of NET is higher than that of 18 F-FDG PET/CT in NETs, while the value of 18 F-FDG PET/CT cannot be ignored in the NET. The combined application of the 2 tracers has major clinical significance in the management of patients with NET.

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Section: Data Availabilitymentioning

confidence: 94%

Section: Ga-dotatate Pet/ct Imagingmentioning

confidence: 99%

Section: Data Availabilitymentioning

confidence: 99%

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Comparison of the application of 18F-FDG and 68Ga-DOTATATE PET/CT in neuroendocrine tumors: A retrospective study

Wang

et al. 2023

Medicine

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“…However, gallium-68 is more suitable for routine procedures because of the on-site production from generators, the high price and insu cient commercial availability of Cu-64 [22][23] and the efforts spent by our group in developing and validating [68Ga]68Ga-based targeted tracers gallium-68 for PET imaging in the clinical and research context [24][25][26][27][28].…”

Section: Introductionmentioning

confidence: 99%

Scale down and optimized automated production of [68Ga]68Ga-DOTA-ECL1i PET tracer targeting CCR2 expression

Migliari

Scarlattei

Baldari

et al. 2023

Preprint

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Background: recently it has been identified a short peptide that showed allosteric antagonism against C-C motif chemokine receptor 2 (CCR2) expressed on inflammatory monocyte and macrophages. A 7-D-amino acid peptidic CCR2 inhibitor called extracellular loop 1 inverso (ECL1i), d(LGTFLKC) has been identified and labeled to obtain a new probe for positron emission tomography in pulmonary fibrosis, heart injury, abdominal aortic aneurysm inflammation, atherosclerosis, head and neck cancer. Our goal was to develop, optimize and validate an automated synthesis method and quality control system for [68Ga]68Ga-DOTA-ECL1i to make it available for a broader community. The synthesis of [68Ga]68Ga-DOTA-ECL1i was done using the Scintomics GRP® module with the already estabilished synthesis template for [68Ga]68Ga-DOTATOC/[68Ga]68Ga-PSMA. The radiopharmaceutical production was optimized using different amount of DOTA-ECL1i (from 50 μg to 10 μg), evaluating synthesis efficiency and relevant quality control parameters in accordance with the European Pharmacopeia. Results: best results were yielded with 20 μg DOTA-ECL1i and then the process validation was carried out by producing three different batches on three different days obtaining an optimal radiochemical yield (66,69%) as well as radiochemical purity (100%) and molar activity (45.41 GBq/µmol). Conclusions: [68Ga]68Ga-DOTA-ECL1i was successfully synthesized and it is, thus, available for multi-dose application in clinical settings.

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“…During the labeling process, different concentrations and volumes of buffer solutions may be used to adjust the acid pH of the eluate [ 68 Ga]GaCl 3 that is obtained from the 68 Ge/ 68 Ga generator [ 27 ].…”

Section: Introductionmentioning

confidence: 99%

A Specific HPLC Method to Determine Residual HEPES in [68Ga]Ga-Radiopharmaceuticals: Development and Validation

et al. 2022

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Background: Nowadays, in Nuclear Medicine, clinically applied radiopharmaceuticals must meet quality release criteria such as high radiochemical purity and radiochemical yield. Many radiopharmaceuticals do not have marketing authorization and have no dedicated monograph within European Pharmacopeia (Ph. Eur.); therefore, general monographs on quality controls (QCs) have to be applied for clinical application. These criteria require standardization and validation in labeling and preparation, including quality controls measurements, according to well defined standard operation procedures. However, QC measurements are often based on detection techniques that are specific to a certain chromatographic system. Several radiosyntheses of [68Ga]Ga-radiopharmaceuticals are more efficient and robust when they are performed with 2-[4-(2-hydroxyethyl)piperazin-1-yl] ethanesulfonic acid (HEPES) buffer, which is considered as an impurity to be assessed in the QC procedure, prior to clinical use. Thus, Ph. Eur. has introduced a thin-layer chromatography (TLC) method to quantify the HEPES amount that is present in [68Ga]Ga-radiopharmaceuticals. However, this is only qualitative and has proven to be unreliable. Here we develop and validate a new high-performance liquid chromatography (UV-Radio-HPLC) method to quantify the residual amount of HEPES in 68Ga-based radiopharmaceuticals. Method: To validate the proposed UV-Radio-HPLC method, a stepwise approach was used, as defined in the guidance document that was adopted by the European Medicines Agency (CMP/ICH/381/95 2014). The assessed parameters are specificity, linearity, precision (repeatability), accuracy, and limit of quantification. A range of concentrations of HEPES (100, 80, 60, 40, 20, 10, 5, 3 μg/mL) were analyzed. Moreover, to test the validity and pertinence of our new HPLC method, we analyzed samples of [68Ga]Ga-DOTATOC; [68Ga]Ga-PSMA; [68Ga]Ga-DOTATATE; [68Ga]Ga-Pentixafor; and [68Ga]Ga-NODAGA-Exendin-4 from different batches that were prepared for clinical use. Results: In the assessed samples, HEPES could not be detected by the TLC method that was described in Ph. Eur. within 4 min incubation in an iodine-saturated chamber. Our developed HPLC method showed excellent linearity between 3 and 100 μg/mL for HEPES, with a correlation coefficient (R2) for calibration curves that was equal to 0.999, coefficients of variation (CV%) < 2%, and percent deviation value of bias from 100% to 5%, in accordance with acceptance criteria. The intra-day and inter-day precision of our method was statistically confirmed and the limit-of-quantification (LOQ) was 3 μg/mL, confirming the high sensitivity of the method. The amount of HEPES that was detected with our developed HPLC method in the tested [68Ga]Ga-radiopharmaceuticals resulted well below the Ph. Eur. limit, especially for [68Ga]Ga-NODAGA-Exendin-4. Conclusions: The TLC method that is described in Ph. Eur. to assess residual HEPES in [68Ga]-based radiopharmaceuticals may not be sufficiently sensitive and thus unsuitable for QC release. Our new HPLC method was sensitive, quantitative, reproducible, and rapid for QCs, allowing us to exactly determine the residual HEPES amount in [68Ga]Ga-radiopharmaceuticals for safe patient administration.

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Performance and long-term consistency of five Galliform 68Ge/68Ga generators used for clinical Ga-68 preparations over a 4 year period

Cited by 5 publications

References 19 publications

Comparison of the application of 18F-FDG and 68Ga-DOTATATE PET/CT in neuroendocrine tumors: A retrospective study

Comparison of the application of 18F-FDG and 68Ga-DOTATATE PET/CT in neuroendocrine tumors: A retrospective study

Scale down and optimized automated production of [68Ga]68Ga-DOTA-ECL1i PET tracer targeting CCR2 expression

A Specific HPLC Method to Determine Residual HEPES in [68Ga]Ga-Radiopharmaceuticals: Development and Validation

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