Preparation of [68Ga]PSMA-11 for PET–CT imaging using a manual synthesis module and organic matrix based 68Ge/68Ga generator

Nanabala, Raviteja; Anees, Muhammed K.; Sasikumar, Arun; Joy, Ajith; Pillai, M.R.A.

doi:10.1016/j.nucmedbio.2016.05.006

Cited by 38 publications

(25 citation statements)

References 29 publications

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“…Technologies Garching (18). Each synthesis was performed under good manufacturing practices, and quality control was performed for purity, pyrogenicity, and sterility.…”

Section: Methodsmentioning

confidence: 99%

“…Additionally, they were asked to categorize the location of the patient's disease as unknown, prostate bed, pelvic nodes, extrapelvic nodes, soft tissue, or bone. The preimaging survey also asked what test would have been ordered if 68 Ga-PSMA-11 PET were not available, including MRI, CT, 18 F-FDG or choline PET, bone scanning, ProstaScint, and image-guided biopsy. On the postimaging survey, the clinicians were asked if the ordering of a test had been prevented; they also were asked to list which test had not been ordered because of the 68 Ga-PSMA-11 PET results.…”

Section: Surveys and Analysismentioning

confidence: 99%

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Impact of ⁶⁸Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer

et al. 2017

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The purpose of this prospective study was to estimate the effect of Ga-labeled prostate-specific membrane antigen (PSMA)-11 PET on the intended management of patients with biochemically recurrent prostate cancer. Pre- and postimaging surveys were filled out by the referring providers for patients with biochemical recurrence who were imaged using Ga-PSMA-11 PET. The inclusion criterion for this study was a prostate-specific antigen (PSA) doubling time of less than 12 mo after initial treatment (NCT02611882). Of the 150 consecutive patients imaged, 126 surveys were completed (84% response rate). The responses were categorized as major change, minor change, no change, or unknown change. There were 103 patients (82%) with disease detected on Ga-PSMA-11 PET. On the basis of the survey results, there were 67 patients (53.2%) with major changes in management and 8 patients (6.4%) with minor changes. The proportion of cases resulting in a change in management did not significantly differ by baseline PSA level. In patients with PSA levels below 0.2 ng/dL, 7 of 12 patients had disease detected onGa-PSMA-11 PET, 5 of whom had a major change in management. Ga-PSMA-11 PET resulted in a major change in management in 53% of patients with biochemical recurrence. Further studies are warranted to investigate whether PSMA-based management strategies result in improved outcomes for patients.

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“…Technologies Garching (18). Each synthesis was performed under good manufacturing practices, and quality control was performed for purity, pyrogenicity, and sterility.…”

Section: Methodsmentioning

confidence: 99%

Section: Surveys and Analysismentioning

confidence: 99%

Impact of ⁶⁸Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer

et al. 2017

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“…The product that remained on the C18 cartridge will pass through a 0.22 μ m pore size filter by ethanol (60%) injection via “B” and will be collected in the product vial. Ethanol concentration in product was no more than 10% before use [ 14 ].…”

Section: Methodsmentioning

confidence: 99%

Preparation of ⁶⁸Ga-PSMA-11 with a Synthesis Module for Micro PET-CT Imaging of PSMA Expression during Prostate Cancer Progression

Wang

Shao

et al. 2018

Contrast Media & Molecular Imaging

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Objective To synthesize 68Ga-Glu-urea-Lys(Ahx)-HBED-CC (68Ga-PSMA-11) with a synthesis module and investigate PET-CT imaging to monitor PSMA expression during prostate cancer (PCa) progression and tumor growth in mice bearing subcutaneous PCa xenografts. Method The radiochemical purity and stability of 68Ga-PSMA-11 were determined via radio-HPLC. The PCa cell lines of different PSMA expression levels (PC3, VCAP±, CWR22RV1+, and LNCaP++) were selected to mimic the PCa progression. 68Ga-PSMA-11 biodistribution was studied by dissection method and in vivo imaging with micro PET-CT. The expression levels of PSMA in tumor cells and tissues were analyzed by immunofluorescence, flow cytometry, and western blot. The correlation between PSMA expression and radio-uptake was also evaluated. 2-PMPA preadministration served as a block group. Results The radiochemical purity of 68Ga-PSMA-11 was 99.6 ± 0.1% and stable in vitro for 2 h. The equilibrium binding constant (Kd) of 68Ga-PSMA-11 to LNCaP, CWR22Rv1, PC-3, and VCAP cells was 4.3 ± 0.8 nM, 16.4 ± 1.3 nM, 225.3 ± 20.8 nM, and 125.6 ± 13.1 nM, respectively. Results of tumor uptake (% ID and % ID/g or % ID/cm3) of 68Ga-PSMA-11 in biodistribution and micro PET imaging were LNCaP > CWR22RV1 > PC-3 and VCAP due to different PSMA expression levels. It was confirmed by flow cytometry, western blot, and immunofluorescence. Tumor uptake (% ID/cm3) of 68Ga-PSMA-11 increased with the tumor anatomical volume in quadratic polynomial fashion and reached the peak (when tumor volume was 0.5 cm3) earlier than tumor uptake (% ID). Tumor uptake (% ID/cm3) of 68Ga-PSMA-11 based on functional volume correlated well with the PSMA expression in a linear manner (y = 9.35x + 2.59, R2 = 0.8924, and p < 0.0001); however, low dose 2-PMPA causes rapid renal clearance of increased tumor/kidney uptake of 68Ga-PSMA-11. Conclusions The 68Ga-PSMA-11 PET-CT imaging could invasively evaluate PSMA expression during PCa progression and tumor growth with % ID/cm3 (based on functional volume) as an important index. Low dose 2-PMPA preadministration might be a choice to decrease kidney uptake of 68Ga-PSMA-11.

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“…Already Nanabala et al studied its stability and radiochemical purity and the product was found to be extraordinarily stable, ensuring at the same time a high standard of radiological safety of the operator. In addition, the generator and the modules can be operated several times a day, the production of the radiopharmaceutical is relatively simple, economical and can be performed by an expert technologist (16). However, several studies are currently supporting the feasibility and operational safety of a new radiopharmaceutical, THP-PSMA, labeled in a single step with cold reconstitution by the means of a kit.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2019

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Preparation of [68Ga]PSMA-11 for PET–CT imaging using a manual synthesis module and organic matrix based 68Ge/68Ga generator

Cited by 38 publications

References 29 publications

Impact of ⁶⁸Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer

Impact of ⁶⁸Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer

Preparation of ⁶⁸Ga-PSMA-11 with a Synthesis Module for Micro PET-CT Imaging of PSMA Expression during Prostate Cancer Progression

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

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Preparation of [68Ga]PSMA-11 for PET–CT imaging using a manual synthesis module and organic matrix based 68Ge/68Ga generator

Cited by 38 publications

References 29 publications

Impact of 68Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer

Impact of 68Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer

Preparation of 68Ga-PSMA-11 with a Synthesis Module for Micro PET-CT Imaging of PSMA Expression during Prostate Cancer Progression

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

Contact Info

Product

Resources

About

Impact of ⁶⁸Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer

Impact of ⁶⁸Ga-PSMA-11 PET on Management in Patients with Biochemically Recurrent Prostate Cancer

Preparation of ⁶⁸Ga-PSMA-11 with a Synthesis Module for Micro PET-CT Imaging of PSMA Expression during Prostate Cancer Progression

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