[68Ga]Ga-PSMA-11 was prepared in-house using the commercially purchased precursor PSMA-11 (ABX, Radeberg, Germany). Patients received 1.5 MBq/kg [68Ga]Ga-PSMA-11 for IV and ssIA administration, in line with prostate cancer imaging guidelines.19 (link) IV administration was performed following routine protocol. For ssIA administration, a sheath was placed in either of the groins to secure entrance to the arterial circulation, followed by a routine catheterisation procedure by a board-certified interventional neuroradiologist. Digital subtraction angiography (DSA) and 3D rotational CT was performed using Visipaque 270® (GE Healthcare, USA) as contrast agent, to determine the dominant tumour feeding arteries. After selective catheterisation of the main supplying artery/-ies [68Ga]Ga-PSMA-11 was administered by means of a pump, under supervision of a board-certified nuclear medicine physician and radiation protection officer. From the DSA images, data on the exact localization of the catheter(s), tumour enhancement, shunting and/or preferential flow were recorded for each patient.
Psma 11
Manufactured by Horiba
Sourced in Germany
PSMA-11 is a radiopharmaceutical used in nuclear imaging procedures. It is designed to target and bind to the prostate-specific membrane antigen (PSMA), a protein that is highly expressed on the surface of prostate cancer cells. PSMA-11 is typically labeled with a radioactive isotope, such as Gallium-68, to allow for the visualization and localization of prostate cancer cells using positron emission tomography (PET) imaging.
Automatically generated - may contain errors
Lab products found in correlation
Visipaque 270, by GE Healthcare (1 mentions)
Biograph mct 40, by Siemens (1 mentions)
Psma 617, by Horiba (1 mentions)
Milli q direct q 3uv system, by Merck Group (1 mentions)
Dota tate, by Horiba (1 mentions)
Itlc sg plate, by Agilent Technologies (1 mentions)
Ramona, by Elysia raytest (1 mentions)
Gabi star, by Elysia raytest (1 mentions)
Suprapur, by Merck Group (1 mentions)
Ultrapur, by Merck Group (1 mentions)
Ge 68 ga 68 generator, by Eckert & Ziegler (1 mentions)
7 protocols using psma 11
1
Intra-Arterial Administration of [68Ga]Ga-PSMA-11
2
Ga-68 PSMA-11 Production Protocol
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Good Manufacturing Practice grade Ga-68 PSMA-11 was prepared in-house as per the following protocol. To the Ga-68 eluted from Ge-68/Ga-68 generator with 0.05 HCL, 10 μg PSMA-11 (ABX, Radeberg, Germany) was added in 0.25M sodium acetate, and then the reaction mixture was heated for 10 min at 95°C. For purification, C-18 cartridge was preconditioned with 5 ml of 70% ethanol, purged with air and water. The labeling mixture was passed through the cartridge and the final product was passed through 0.22 μm filter before injecting into the patients. Samples with radiopharmaceutical purity of >95% were used for patient administration.
3
PSMA-11 PET/CT Imaging Protocol
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68Ga ws obtained from a 68Ge/68Ga generator, labelled with the PSMA-11-precursor (ABX, Radeberg, Germany) and administered via an intravenous bolus injection (mean of 109.78 MBq, range 73–148 MBq). For the examination of the patients of this study, a cross-calibrated dedicated PET/CT system, Biograph mCT 40 (Siemens, Erlangen, Germany) was used and a standard acquisition protocol with a whole-body scan (skull base to upper thighs) starting between 58 and 95 min (mean: 70.6 min.) p. i. and three examinations were additionally performed between 120 and 150 min (mean:130 min.) p. i. as part-body scans. Image data analysis was performed using commercially available software (Siemens, Erlangen, Germany). For the calculation of the SUVmax, the volume-of-interest technique was used around the areas with an increased tracer uptake in multiplanar imaging.
PSMA PET during follow-up was not performed routinely, but only in case of repeated increase in serum PSA.
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68Ga ws obtained from a 68Ge/68Ga generator, labelled with the PSMA-11-precursor (ABX, Radeberg, Germany) and administered via an intravenous bolus injection (mean of 109.78 MBq, range 73–148 MBq). For the examination of the patients of this study, a cross-calibrated dedicated PET/CT system, Biograph mCT 40 (Siemens, Erlangen, Germany) was used and a standard acquisition protocol with a whole-body scan (skull base to upper thighs) starting between 58 and 95 min (mean: 70.6 min.) p. i. and three examinations were additionally performed between 120 and 150 min (mean:130 min.) p. i. as part-body scans. Image data analysis was performed using commercially available software (Siemens, Erlangen, Germany). For the calculation of the SUVmax, the volume-of-interest technique was used around the areas with an increased tracer uptake in multiplanar imaging.
PSMA PET during follow-up was not performed routinely, but only in case of repeated increase in serum PSA.
4
PSMA-targeted Radiopharmaceutical Synthesis
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Chemicals and solvents were purchased from Sigma-Aldrich (St. Louis, MO, USA) and Merck (Germany) or otherwise as indicated. Used water and acetonitrile for reagents were from Merck. For staining, PSMA-specific antibody (Abcam Cat# ab19071, RRID:AB_444751) and the goat anti mouse DyLight488 antibody (Abcam Cat# ab96871, RRID:AB_10680543) were used. The CD31-specific antibody (Cat# MA3100, RRID:AB_223516) was purchased from ThermoFisher Scientifics. Precursors PSMA-11 and PSMA-617 were purchased from ABX (Germany) and Endocyte (USA). The nuclides 68Ga and 177Lu were supplied by iThemba (South Africa, generator system) and IDB (The Netherlands), respectively.
5
Radiolabeling of PSMA-11 and DOTATATE
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All water was obtained from a Milli-Q® Direct-Q 3 UV system (Merck Millipore). Ultrapur hydrochloric acid 30% (Merck) was used directly and diluted with water during target dissolution and gallium-68 purification. Hydroxamate-based resin (ZR Resin), di(2-ehtylhexyl)orthophosphoric acid-based resin (LN Resin) and trioctylphosphine-based resin (TK200 Resin) were used for [68Ga]GaCl3 purification (Triskem International, Rennes, France). Labelling was performed with PSMA-11 and DOTATATE (ABX, Dresden, Germany).
6
Radiolabeling of PSMA-11 and Pentixafor
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All chemicals were used without further purification. The precursors, Pentixafor and PSMA-11 (both GMP grade), for 68Ga-labeling were provided from ABX (Radeberg, Germany). All other chemicals were obtained from Sigma Aldrich, Merck, Fluka, or Honeywell. Syntheses were performed using a synthesizer (GRP®) from Scintomics (Fürstenfeldbruck, Germany) with disposable single-use cassettes. TLC for radiochemical purity assessment was done by applying chromatography paper impregnated with silica gel (iTLC-SG plates) purchased from Agilent Technologies (Santa Clara, USA). HEPES testing was performed using silica gel 60 F245 20 × 20 cm aluminum plates and aluminum oxide plates 60 F254 20 × 20 cm obtained from Merck. HPLC analysis was performed using a VWR Hitachi Chromaster system (VWR International, Radnor, USA; pump 5160, column oven 5310, UV detector 5410) and separate scintillation detectors Gabi Star (2 × 2 mm) and Ramona from Elysia-Raytest (Straubenhardt, Germany) controlled by a clarity software from Data Apex (Prague, Czech Republic).
7
Radiolabeling of PSMA-11, EuK-2Nal-AMCH-N-sucDf-Fe
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PSMA-11, EuK-2Nal-AMCH-N-sucDf-Fe, and disposable cassette kits were produced by ABX (Radeberg, Germany). Water (Ultrapur®), hydrochloric acid 30% (Ultrapur®), and sodium hydroxide 30% (Suprapur®) were obtained from Merck Millipore (Steinheim, Germany). Serum was collected from whole blood in serum separator tubes. Zr-89 in 1 M oxalic acid was supplied by Perkin Elmer and produced by BV Cyclotron VU (Amsterdam, Netherland). Ga-68 was eluted in a solution of 0.1 M HCl from a Ge-68/Ga-68-Generator Eckert & Ziegler Radiopharma (Berlin, Germany). The other chemicals used were acquired from Sigma-Aldrich (Darmstadt, Germany).
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