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68Ga-DOTATOC (Gallium (68Ga) edotreotide injection) and related tracers
Gallium-68 is a positron-emitting isotope (t1/2 68 minutes) which is generated from Germanium-68 in Gallium-68 generators, for use in PET.
The development of novel PET tracers which specifically bind to somatostatin receptors (SSTR2-5) permits the visualization of neuroendocrine tumors with higher sensitivity than other imaging procedures. Among these tracers, 68Gallium-DOTA-peptides are increasingly being used for diagnosis and therapy monitoring. Another growing application of Gallium-68 is the targeting of the Prostate-specific membrane antigen (PSMA) overexpression in order to image prostate cancer (PCa) metastases.
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Test |
Technic/instrument |
|
Appearance |
Visual |
|
Radionuclidic Identity |
Gamma-ray spectroscopy with Multichannel analyser |
|
Radionuclidic Identity |
Half-life determination with a dose calibrator |
|
pH |
pH-meter or pH strips with reading through a reflexion photometer |
|
Chemical purity |
Gradient HPLC with UV detector |
|
2-[4-(2-hydroxyethyl)piperazin-1-yl)ethanesulfonic acid (HEPES) test |
Spot test |
|
Ethanol |
Gas chromatography |
|
Bacterial endotoxins (LAL) |
Endosafe Portable Test System (PTS) |
|
Other radiochemical impurities |
Radio-HPLC |
|
Radiochemical purity (68Ga ion) |
Radio-TLC |
|
Radiochemical identity |
Radio-HPLC |
|
Osmolality |
Osmometer |
|
Radionuclidic purity and Germanium-68 impurity |
Gamma-ray spectroscopy with Multichannel analyser |
|
Sterility |
Compendial method |
|
Radioactivity |
Dose calibrator |