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Ge fastlab

Manufactured by GE Healthcare
Sourced in United States, Belgium

The GE FASTlab is a compact and fully automated in-vitro diagnostic system designed for the preparation and analysis of samples in a clinical laboratory setting. The system's core function is to perform sample handling, reagent addition, and reaction monitoring to facilitate efficient and accurate diagnostic testing.

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8 protocols using ge fastlab

1

PET/CT Imaging of [11C]Acetate Uptake

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All patients underwent whole-body PET/CT scanning using a combined PET/CT in-line system (Biograph 64 TruePoint PET/CT system, Siemens, Erlangen, Germany). Patients were injected intravenously with approximately ~740 MBq to 850MBq of [11C]Acetate based on the patient`s bodyweight, and uptake time was 20 minutes. [11C]Acetate was prepared in-house using a fully automated radiosynthesizer (GE FASTlab®, GE Healthcare, USA) with dedicated software and single-use cassettes produced under good manufacturing practice (GMP).
A supine PET dataset (4–5 bed positions, 3min/ bed position) from the base of the skull to mid-thigh and a low-dose, unenhanced CT scan (spiral scanning; Sl/pitch 3.0/0.55mm, 120kV, 230mAs) for attenuation correction and image registration was obtained. The PET data was reconstructed using the TRUE-X algorithm with four iterations (21 subsets, 168x168 Gaussian filter, FWHM 3mm).
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2

Radiolabeling protocol for [18F]Me4FDG PET tracer

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[18F]Me4FDG was prepared in-house following a standardized protocol, using a GE FASTlab synthesizer (GE Healthcare, Boston, MA, USA) with dedicated disposable cassettes on the day of PET imaging. A regular cassette for [18F]FDG was used and prepared as follows: The FDG-precursor-vial was removed and exchanged to a 11 mL crimp-vial, filled with a solution of 10 mg GMP compliant precursor for Me4FDG (β-D-Galactopyranoside, methyl, 2,3,6-triacetate 4-trifluoromethanesulfonate, obtained from ABX advanced biochemical compounds GmbH, Radeberg, Germany) in 2 mL acetonitrile. Full radiopharmaceutical quality control according to the monographs of the European Pharmacopoeia (Ph. Eur.) was thoroughly performed prior the release of the tracer and application to the patient. The prepared cassette lost its GMP compliant due to the manipulation but since a radiosynthesis for a subsequent in-house application at the Vienna General Hospital is exempt from any GMP regulation, this route could be taken.
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3

PET Tracer Synthesis and Quality Control

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The applied 2-[18F]fluoro-2-deoxyglucose ([18F]FDG) was produced in-house at the Interdisciplinary PET-Centre (IPZ) of the University Hospital Würzburg using the GE-PETtrace cyclotron and the GE-Fastlab® synthesis unit (GE Medical Systems, Uppsala, Sweden) as previously described (Israel et al., 2016 ; Lapa et al., 2016 (link)). A computer-assisted synthesis-module (Scintomics, Fürstenfeldbruck, Germany) was used for the synthesis of [68Ga]Ga-Fucoidan, as described previously (Li et al., 2014 (link)). Both radiotracers were manufactured under sterile conditions for clinical ([18F]FDG) and preclinical ([68Ga]Ga-Fucoidan) applications and were analyzed for radiochemical purity by HPLC and TLC before application.
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4

Automated Radiolabeling of PSMA-617 and RM2

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PSMA-617 and RM2 were radiolabeled with 111In using an automated synthesizer (GE FastLab, GE Healthcare, GEMS Benelux, Belgium). Briefly, 40 μg of RM2 (Life Molecular Imaging) or PSMA-617 (ABX GmBH) was heated at 90 °C for 5 min using microwaves or 111InCl3 (CURIUM®) and 5 mg of ascorbic acid for RM2. The raw solution was then purified on a C18 cartridge (WAT023501) preconditioned with 1 mL ethanol (Merck®) and 5 mL water (GE®). The final product was then eluted with 1 mL ethanol and formulated in PBS. 111In-RM2 and 111In-PSMA-617 were checked for radiochemical purity and amount using radio-UV-HPLC (Phenomenex Luna C18; 250 mm × 4.6 mm × 5 μm; 2.5 mL/min, λ = 220 nm; eluent A comprising 0.1% TFA in water, eluent B comprising acetonitrile; gradient 0–10 min, 95% to 5% A). The analytical HPLC system used was a JASCO system with ChromNAV software, a PU-2089 Plus quaternary gradient pump, a MD-2018 Plus photodiode array detector, and Raytest Gabi Star detector.
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5

Prone [18F]FDG PET/CT Imaging of Breast Cancer

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[18F]FDG was prepared in-house using a fully automated radiosynthesizer (GE FASTlab®, GE Healthcare, USA) with dedicated software and single-use cassettes [32 (link)–33 (link)].
Prone [18F]FDG PET/CT of the breast was performed using a combined whole-body PET/CT in-line system (Biograph 64 TruePoint®; Siemens, Erlangen, Germany) equipped with a high-resolution PET scanner and a 64-row detector CT scanner. Prior to injection of the radiotracer, patients fasted for at least five hours. If plasma glucose was less than 150 mg/dl (8.3 mmol/l), each patient was injected intravenously with 200–350 MBq [18F]FDG based on body weight. After [18F]FDG injection, patients rested for a 60 min uptake period. This was followed by image acquisition where initially, a prone low-dose CT scan without contrast agent from the base of the skull to the upper abdominal region was acquired for attenuation correction and subsequently, a high-resolution, prone PET dataset was recorded over the same region. Raw data were reconstructed using an ordered subset expectation maximization (OSEM) algorithm with point spread function correction (PSF) correction (“TrueX”) [34 (link)–36 (link)]. Four iterations with 21 subsets were used, with a matrix size of 168×168 (pixel size 4.1 × 4.1 mm) and a slice thickness of 5 mm. No post-reconstruction filter was applied (“ALLPASS” option).
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6

In-House Synthesis of PET Tracers

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[18F]FDG and [18F]fluoride were synthesized in house (GE FASTlab®; GE Healthcare, Piscataway, NJ, USA) with dedicated software and single‐use cassettes (FastLab Casettes, GE Healthcare).
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7

Synthesis and QC of Me-4-[18F]FDG Tracer

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Me-4-[18F]FDG was prepared in-house following a standardized protocol, using a GE FASTlab synthesizer (GE Healthcare, Boston, MA, USA) with dedicated disposable cassettes on the day of PET imaging. A regular FDG cassette was used and prepared as follows: The FDG-precursor-vial was removed and exchanged to a 11-mL crimp-vial, filled with a solution of 10 mg precursor for Me4FDG (β-d-galactopyranoside, methyl, 2,3,6-triacetate 4-trifluoromethanesulfonate, obtained from ABX advanced biochemical compounds GmbH, Radeberg, Germany) in 2 mL acetonitrile. Full radiopharmaceutical quality control according to the monographs of the European Pharmacopoeia (Ph. Eur.) was thoroughly performed prior to the release of the tracer and application to the patient. The production is not GMP compliant anymore but not necessary for in-house production within the General Hospital of Vienna.
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8

Automated Radiolabeling of RM2 Peptide

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Radiolabelling experiments were performed on an automated synthetisor (GE FastLab, GE Healthcare, GEMS Benelux, Belgium). Briefly, 40μg of RM2 (Life Molecular Imaging) was heated at 90°C during 5min using micro-waves with 1.1 mL 68GaCl3 (GalliEo generator with nominal activity of 1850 MBq, IRE Elit, Belgium) and 5mg of ascorbic acid. The raw solution was then purified on a C18 cartridge (WAT023501) preconditioned with 1mL ethanol (Merck) and 5 mL water (GE Healthcare). The final product was then eluted with 1 mL ethanol and formulated in PBS. 68Ga-RM2 was checked for radiochemical purity using HPLC (Phenomenex Luna C18; 250mm x 4.6mm x 5μm; 2.5 mL/min, λ = 220nm). The analytical HPLC system used was a JASCO system with ChromNAV software, a PU-2089 Plus quaternary gradient pump, a MD-2018 Plus photodiode array detector and Raytest Gabi Star detector. Amount of 68Ga-RM2 was determined by UV-HPLC by linear regression of the calibration curve established using the reference compound natGa-RM2 (Life Molecular Imaging).
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