personalized gifts [2:10 half lives of radioactive decay for 11 C isotope) after administration of the drug or avoid use of the drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effectiveness of Choline C11 Injection have not been established in pediatric patients. Choline C 11 Description Chemical Characteristics Choline C11 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with PET imaging. The active ingredient, 11 C-choline, has the molecular formula of C 4 CH 14 NOCl with a molecular weight of 138.63 g and has the following chemical structure: Choline C11 Injection is provided as a ready to use sterile, pyrogen-free, clear and colorless solution. Each milliliter contains 148 MBq to 1225 MBq (4 mCi to 33.1 mCi) of 11 C-choline at EOS calibration time in aqueous 0.9% sodium chloride solution. The pH of the solution is between 4.5 and 7.5. Physical Characteristics Carbon 11 is a cyclotron-produced radionuclide that decays to Boron 11 by positron emission and has a physical half life of 20.4 minutes (Table 2). Table 2: Principal Radiation Emission Data for 11 C Radiation / Emission % Per Disintegration Energy Positron ( +) 99.76 960.2 keV (Max.) Gamma ( )* 199.5 511 keV * Produced by positron annihilation The specific gamma ray constant (point source air kerma coefficient) for 11C-choline is 5.8 R/mCi-hr at 1 cm. Selected coefficients of attenuation are listed in Table 3 as a function of lead shield thickness. For example, the use of 39 mm thickness of lead will attenuate the external radiation by a factor of about 1,000. Table 3: Radiation Attenuation of 511 keV Photons by lead (Pb) shielding Shield Thickness (Pb) mm Coefficient of Attenuation 4 0.5 8 0.25 13 0.1 26 0.01 39 0.001 52 0.0001 Table 4 lists fractions remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide. Table 4: Physical Decay Chart for 11 C Minutes Fraction Remaining 0* 1.000 5 0.844 10 0.712 15 0.600 20 0.507 25 0.427 30 0.360 * Calibration Time Choline C 11 - Clinical Pharmacology Mechanism of Action Choline C 11 Injection is a radiolabeled analog of choline, a precursor molecule essential for the biosynthesis of cell membrane phospholipids. Choline is involved in synthesis of the structural components of cell membranes, as well as modulation of trans- membrane signaling. Increased phospholipid synthesis (i.e., increased uptake of choline) has been associated with cell proliferation and the transformation process that occurs in tumor cells. Pharmacodynamics In a study of men with prostatic hyperplasia or primary prostate cancer, PET imaging showed 11 C-choline radioactivity accumulated rapidly within the prostate; uptake appeared to peak by five minutes following injection of the drug and activity was retained over the subsequent 30 minute scanning period. Little uptake was observed in the bladder and rectum. Pharmacokinetics Distribution : 11 C-choline distributes mainly to the pancreas, kidneys, liver, spleen and colon [ see Dosage and Administration ( 2.4 )]. Based upon the relatively low urinary excretion of radioactivity, renal distribution is predominantly to the organ itself, rather than via formation of urine. Metabolism : Following intravenous administration, 11 C-choline undergoes metabolism resulting in the detection of 11 C-betaine as the major metabolite in blood. In a study of patients with prostate cancer or brain disorders, the fractional activities of 11 C-choline and 11 C-betaine in human arterial plasma appeared to reach a plateau within 25 minutes, with 11 C-betaine representing 82% 9% of the total 11 C detected at that time point. A small amount of unmetabolized 11 C-choline was detected within the blood at the final sampling time point (40 minutes). Elimination : Urinary excretion of 11 C-choline was] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only Approval History Drug history at FDA Related Drugs Positron Emission Tomography Imaging choline c-11 , Vizamyl , Amyvid , Netspot , flutemetamol f-18 , florbetaben f-18 , fluciclovine F 18 , More... Choline c-11 Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! sensible
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