NMTCB PET CERTIFICATION REVIEW QUESTIONS AND ANSWERS (GRADED A)
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NMTCB PET CERTIFICATION
Institution
NMTCB PET CERTIFICATION
NMTCB PET CERTIFICATION REVIEW QUESTIONS AND ANSWERS (GRADED A)NMTCB PET CERTIFICATION REVIEW QUESTIONS AND ANSWERS (GRADED A)NMTCB PET CERTIFICATION REVIEW QUESTIONS AND ANSWERS (GRADED A)
Rb-82 Genertaor Alert Level - ANSWER-14L of eleute volume reached, or Sr-82 level 0.002uCi/mCi of Rb-82, o...
NMTCB PET CERTIFICATION REVIEW
QUESTIONS AND ANSWERS (GRADED
A)
Rb-82 Genertaor Alert Level - ANSWER-14L of eleute volume reached, or Sr-82 level
0.002uCi/mCi of Rb-82, or Sr-85 level 0.02uCi/mCi of Rb-82
Actions for Rb82 Generator Alert Level - ANSWER-Test after every 750 mL has passed
through generator
Stop using Rb-82 generator if - ANSWER-17L of eleute volume reached, or 42 days
post calibration date, or Sr82 levenis 0.01uCi/mCi of Rb82, or Sr85 level reaches
0.1uCi/mCi of Rb82
Cyclotron produced isotopes and half-life - ANSWER-C11, 20.3 min; N13 9.97 min; O15
2.03 min; F18, 109.7 min
Advantages of negative ion cyclotrons - ANSWER-1) less nuclear activation of cyl
potion cavity and surroundings, 2) can self-focus beam of particles, 3) can irradiate 2
targets at once
Any product with a half-life greater than ____ minutes must pass quality control testing
before released for human use - ANSWER-20 minutes
According to USP, F18-FDG must have a labeling efficiency of greater than ___ -
ANSWER-90%
What quality control tests for F18-FDG cannot be performed before patient use -
ANSWER-Sterility
The initial precursor molecule for producing FDG is - ANSWER-mannose triflate
Due to high radioactivity, the production of PET Rx's must be done in lead-shield hot
cells with automated systems called - ANSWER-synthesis modules
Isotopes produces by negative ion cyclotrons - ANSWER-C, N, O = metabolites
Reaction for chemical labeling of F18-FDG - ANSWER-Nucleophilic substitution
Chemical reaction of FDG - ANSWER-Electron rich group of atoms change place on
molecule with a positively charged leaving group
,Precursor molecule for FDG - ANSWER-Mannose triflate
Chem formula of FDG - ANSWER-2-deoxy-2-[18F]fluoro-D-glucose. (Fludeoxyglucose
F-18)
Intermediate step in FDG synthesis - ANSWER-Alkaline hydrolysis of 4 acetyl groups by
replacing with OH
Size filter used after purification - ANSWER-0.22 um
FDA ref for PET pharma production - ANSWER-General chapter 823
FDG QA appearance - ANSWER-Colorless liquid
FDG QA radiochemical identity - ANSWER-Thin-layer chromatography Rf value to
reference standard
FDG QARadionuclide identity - ANSWER-Half-life 105 and 115 minutes
FDG QA bacterial endotoxins test - ANSWER-LAL (Limulus amebocyte lysate) <175
USP endotoxins units per max volume injection; endotoxins< 17.5 EU
FDG QC pH - ANSWER-Between 4.5 to 7.5
FDG QA Radiochemical purity - ANSWER-Thin-layered chromatography radioactive Rf
should be not less than 90% of total radioactivity of chromatography plate
FDG QC Radionuclideic purity - ANSWER-should be >99.5% of radionuclidie specified.
tested using multi-channel analyzer with peaks at 0.511 and 1.022 MeV
FDG QC chemical purity - ANSWER-testing depends upon synthesis method used to
create FDG
Kryptofix 222 - ANSWER-FDG QC chemical purity test - thin-layer paper
chromatography spot test. 50 ug/mL and FDG solution must demonstrate a less intense
response than standard
2-Chloro-2-deoxy-D-glucose - ANSWER-FDG QC chemical purity test used if hydrolysis
step was performed with hydrochloric acid. Use high-performance liquid
chromatography using an electrochemical detector. Mus not have more than 1 mg
CLDG: 2-deoxy-2-D-glucose
FDG QC Residual solvents - ANSWER-solvents can be in FDG from cleaning or
synthesis solutions. solutions may contain acetonitrle, ether anddehydrated alcohol. no
more 0.04% acetonitrle, and less than 0.5% of ether or ethanol
, Production of C-11 Palmitate - ANSWER-Produce 11CO2 in cyclotron. React with
pentadecylmagnesium bromide to form 11C-Palmitate and purified.
Procedure for imaging with C-11 Palmitate - ANSWER-NPO 6 hrs. Place patient on
scanner and injected and 5 min uptake then scan.
F-18 FDG method of localization - ANSWER-Glucose analog transported across cell
membrane. Cells metabolized FDG my phosphorylation by hexokinase to make FDG-6-
phosphate and stays in cells.
Normal biodistribution of FDG - ANSWER-Brain, myocardium, moderate in
nasopharyngeal region,mild in muscle, liver, spleen and testes (suv appox 2). FDG is
glomerulus filtered so in bladder, ureter and kidneys
FDG QC Sterility - ANSWER-not performed before dosing due to need of 14 days to
perform. Regulations require final produce to be placed in soy broth mixture with a
thioglycollate growth media for 30 hrs. look for observable bacteria
FDG QC Filter membrane integerity - ANSWER-final sterility filter used at end of
manufacturing process. Filter must remain intact as pressure increased to 50 psi
(bubble point test)
FDG synthesis room requirements - ANSWER-room: cGMP, ISO class 5 clean room air
hood, 21 CFR 212 for manufacturing of IV drugs
which radiouclides are possible radioactive contaminates in eluent of Rb82 generators -
ANSWER-Sr82 and Dr85
negative ion PET cyclotrons accelerate which partiles - ANSWER-negatively charged
hydrogen atoms
chemical method used to label F18 to glucose - ANSWER-nucleophilic substitution
The least amount of energy needed by bombarding particles used for nuclear reactions
occurring within a cycltron - ANSWER-8 Mev
Most common irradiation process of producing F18 with an 109.7 min half-life -
ANSWER-O15(p,n)F18
1 mCi = X MBq - ANSWER-37
Webster Ped dose - ANSWER-Dose(adult) x (Age+1)/(Age+7)
Clark Ped Dose - ANSWER-Dose(Adult) x (child weight/150 pds)
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