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Long NamePET Imaging Agent NCI Standard Template
DefinitionThe collection of CDEs used in the PET imaging agent modules.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowDRAFT NEW
TypeCRF
Public ID3476227
Version1.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionQuestion InstructionsValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Mandatory PET Imaging Agent Questions These items must be included when this data is collected for reporting.
Agent NameAgent Name104.0CHARACTER
Study Treatment Identification NumberAgent Lot Identifier Number625923.0CHARACTER
PET imaging agent sourcePET Imaging Agent Source Type27183683.0CHARACTER
Obtained from outside supplierObtained from outside supplierThe radiosotope is obtained from a supplier that attests that its production of FDG is compliant with relevant USP standards
Prepared in-housePrepared in-houseThe radioisotope is manufactured on site and the site attests that its production is compliant with relevant USP standards.
PurchasedPurchasedFDG is obtained from a supplier that attests that its production of FDG is compliant with relevant USP standards.
SynthesizedSynthesizedFDG is manufactured on site and the site attests that its production is compliant with relevant USP standards.
Method [of synthesis]PET Imaging Agent Manufactured Method Text31658391.0CHARACTER
SupplierAgent Supplier Name29719771.0CHARACTER
Was imaging agent administered?Imaging Agent Administered Yes or No Response31658451.0CHARACTER
NoNoThe non-affirmative response to a question.
YesYesThe affirmative response to a question or activity.
Date Agent AdministeredAgent Administered Date20063994.0DATEMM/DD/YYYY
Route of AdministrationAgent Administration Type625896.0CHARACTER
InhaledInhalation Route of AdministrationAdministration of a substance in the form of a gas, aerosol, or fine powder via the respiratory tract, usually by oral or nasal inhalation, for local or systemic effect.
Bolus injectionBolus injectionBolus injection
IMINTRAMUSCULAR ADMINISTRATION OF DRUGINTRAMUSCULAR ADMINISTRATION OF DRUG
InfusionINFUSIONINFUSION
injection/implantinjection/transdermalinjection/transdermal
IntramuscularIntramuscularIntramuscular
IVINTRAVENOUS ADMINISTRATION OF DRUGINTRAVENOUS ADMINISTRATION OF DRUG
nasalnasal route of administrationAdministration of a drug by the way of the nose. This often results in systemic action of the agent due to absorption through the nasal mucosa. The richly supplied vascular nature of the nasal mucosa coupled with its high drug permeation makes the nasal route of administration attractive for many drugs, including proteins and peptides.
OcularOCULAROCULAR
oralORAL ADMINISTRATION OF DRUGORAL ADMINISTRATION OF DRUG
OtherOtherNot otherwise specified.
POORAL ADMINISTRATION OF DRUGORAL ADMINISTRATION OF DRUG
SubcutaneousSubcutaneousSubcutaneous
transdermal/topicalNDC TRANSDERMAL - 358NDC TRANSDERMAL - 358
vaginalvaginal route of administrationAdministration of a drug into the vagina. The medication usually has the form of a solution, tablet, cream, gel, or suppository. The drug is slowly absorbed through the vaginal wall with predominantly local, but some systemic effects.
Location of Injection SitePET Isotope Injection Anatomic Site Code27147602.0CHARACTER
1Right antecubitalRight antecubital
2Right wristRight wrist
3Left antecubitalLeft antecubital
4Left wristLeft wrist
5Right footRight foot
6Left footLeft foot
88Other, specifyOther, specify
99UnknownNot known, not observed, not recorded, or refused.
Location of injection site, Other specifyPET Isotope Injection Other Specify27148771.0CHARACTER
Activity in full syringe before injectionPET Isotope Begin Dose Assay Value27324172.0NUMBERmCi
Time of assay of full syringe before injectionPET Isotope Begin Dose Assay Time27165981.0TIMETIME (HR(24):MN)
Time of injectionPET Isotope Injection Start Time27166001.0TIMETIME (HR(24):MN)
Residual activity in syringe after injectionPET Isotope Residual Dose Assay Isotope Value27167742.0NUMBERmCi
Time of assay of residual activity after injectionPET Isotope Residual Dose Assay Time27167721.0TIMETIME (HR(24):MN)
Net activity administeredImaging Agent Net Radioactivity Administered Float 16 Character Number29758581.0CHARACTER
Any radiotracer infiltration at injection site noted?PET Isotope Infiltration Infiltration Type27165222.0CHARACTER
Minor (<= 20% of dose)Minor infiltration is estimated to be less than or equal to 20% of doseMinor infiltration is estimated to be less than or equal to 20% of dose
NoneNo infiltration of radiotracerNo infiltration of radiotracer
Severe (> 20% of dose)Severe infiltration is estimated to be more than 20% of doseSevere infiltration is estimated to be more than 20% of dose
Conditional PET Imaging Agent QuestionThere are business rules to indicate situations under which these elements should be used on a case report form.
Imaging Agent NamePET Imaging Agent Identifier Imaging Agent Name31658342.0Use when an imaging agent is included in trial.CHARACTER
Cu-64 ATSMCu-64 ATSMCu-64 ATSM
F-18 FDGF-18 FDGF-18 FDG
F-18 FLTF-18 FLTF-18 FLT
F-18 FluorideF-18 FluorideF-18 Fluoride
F-18 Fluorodihydrotestosterone (FDHT)F-18 Fluorodihydrotestosterone (FDHT)F-18 Fluorodihydrotestosterone (FDHT)
F-18 FluorodopaF-18 FluorodopaF-18 Fluorodopa
F-18 Fluoroestradiol (FES)F-18 Fluoroestradiol (FES)F-18 Fluoroestradiol (FES)
F-18 FMISOF-18 FMISOF-18 FMISO
Ga-68 DOTA-NOCGa-68 DOTA-NOCGa-68 DOTA-NOC
Ga-68 DOTATOCGa-68 DOTATOCGa-68 DOTATOC
I -124 IodideI -124 IodideI -124 Iodide
Optional PET Imaging Agent QuestionsThere is no requirement for inclusion of these elements on the case report form. If the design and scientific questions posed in the study dictate the need to collect this type of data, these elements should be included.
Pyrogen test resultsPET Imaging Agent Pyrogen Test Result Type31658651.0CHARACTER
FailedFailedFailed test
Not DoneNot DoneTesting not done
PassedPassedPassed test
Radiochemical purity test resultPET Imaging Agent Radiopharmaceutical Purity Test Result Number31658731.0CHARACTER