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Tracerlab fxfdg

Manufactured by GE Healthcare
Sourced in United States

The TRACERlab FXFDG is a radiochemistry synthesis module designed for the automated production of 18F-FDG, a widely used radiotracer in positron emission tomography (PET) imaging. The module provides a controlled environment for the synthesis, purification, and formulation of 18F-FDG in compliance with current good manufacturing practices (cGMP) requirements.

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4 protocols using tracerlab fxfdg

1

Standardized 18F-FDG PET/CT Imaging Protocol

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18F-FDG PET/CT scans were performed using a Biograph mCTx scanner (Siemens, Germany). The patients were instructed to fast for at least 6 h, and their blood glucose levels were monitored with a glucometer prior to 18F-FDG injection. All the patients had blood glucose levels below 7.0 mmol/L. 18F-FDG was manufactured using a tracer synthesis system (TRACERlab FXFDG; GE Healthcare, United States) and had a > 95% radiochemical purity. Approximately 60 min after the intravenous injection of 318-524 MBq (8.6-14.2 mCi, 150 μCi/kg) 18F-FDG, whole-body PET/CT was performed at our centre according to established protocols[24 (link)].
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2

Standardized 18F-FDG PET/CT Imaging Protocol

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All patients underwent PET/CT examinations using the Philips TF64 PET/CT scanner. The 18 F-FDG was synthesised using a GE MINItrace cyclotron and Tracerlab FX-FDG synthesiser, with precursor reagents purchased from ABX, Germany. The synthesised 18 F-FDG had a radiochemical purity of ≥ 95%, met quality control standards, and was suitable for human injection. The patients fasted for at least 6 h, with a fasting blood glucose level of ≤ 12 mmol/L. The 18 F-FDG was injected into the vein of the contralateral upper limb of the affected breast at a dose of 370 MBq/kg body weight. Patients were encouraged to drink water and remained at rest for 60 min. The scanning range was from the skull vertex to the midthigh. The CT scan parameters were as follows: tube voltage of 120 kV, tube current of 300 mA, slice thickness of 5 mm, interslice gap of 5 mm, and 512 × 512 matrix. PET data were acquired in 3D mode for 1.5 min per bed position covering six to seven bed positions. The PET images underwent attenuation correction by using co-registered CT data and were reconstructed using iterative reconstruction and time-of-flight techniques. The image data were then transferred to the Philips Extended Brilliance Workspace (EBW) workstation for post-processing.
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3

Automated Synthesis of 18F-FDG and 18F-FAPI-04

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18F-FDG was automatically manufactured at the PET/CT department of Harbin Medical University Cancer Hospital by the standard preparation methods applying the coincidence 18F-FDG synthesis module (TracerLab Fx FDG; GE Healthcare, Milwaukee, Wis). Radiolabeling of 18F-FAPI-04 was performed using a previously described protocol. The FAPI precursor (1,4,7-triazacyclononane-1,4,7-triacetic acid) [NOTA] FAPI-04). Quality control of the radiosynthesis was performed by ultraviolet and radio high-performance liquid chromatography (HPLC). Radiochemical purity exceeded 95% for both 18F-FAPI-04 and 18F-FDG, and the final product was diluted and sterilized. The sterility tests were conducted in the radiochemistry facility of Harbin Medical University Cancer Hospital. Finally, 18F-FDG and 18F-FAPI-04 have to conform to all set criteria prior to their transformation into the clinic for human administration. The synthesis process of 18F‑FAPI‑04 is described in supplementary data 1, and the corresponding chemical structural formula is displayed in supplementary data 2.
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4

FDG-PET/CT Imaging Protocol for Metabolic Evaluation

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Patients fasted for at least 6 h before the CT and PET scans. The patient blood glucose levels were controlled below 110 mg/ml. 18 F-FDG (MiniTrace II and TracerLab FX-FDG, purity > 99%; GE Healthcare, Waukesha, Wisconsin, USA) was administered at a dose of 3.7 MBq/kg. The patients underwent the PET/CT (Discovery PET/CT 690; GE Healthcare, USA) scan after 60 min of quiet rest. A low-dose attenuation-corrected CT scan (120 kV, 80 mA) was performed (thickness 3.75 mm), ranging from the base of the skull to the middle of the thigh. A three-dimensional PET scan was then performed on a total of seven beds at a speed of 1.5 min/bed. Using 24 subsets and two iterations, the PET images were reconstructed by the ordered-subsets expectation maximization (OSEM) algorithm with attenuation correction. Time-of-flight and point-spread function techniques were used in the reconstruction.
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