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2014-04-07_PET_Imaging_Agent_NCI_Standard_Template-508_Compl.xlsx
| Long Name | PET Imaging Agent NCI Standard Template | ||||||||||
| Definition | The collection of CDEs used in the PET imaging agent modules. | ||||||||||
| Context | caBIG | ||||||||||
| Protocol Long Name | NCI Standard Template Forms | ||||||||||
| Workflow | RELEASED | ||||||||||
| Type | CRF | ||||||||||
| Public ID | 3476227 | ||||||||||
| Version | 1.0 | ||||||||||
| Module Long Name | Module Instructions | Question | CDE | CDE Public ID | CDE Version | Value Domain Data Type | Value Domain Unit of Measure | Display Format | Valid Value | Form Value Meaning Text | Form Value Meaning Desc. |
| Mandatory PET Imaging Agent Questions | These items must be included when this data is collected for reporting. | ||||||||||
| Study Treatment Identification Number | Agent Lot Identifier Number | 62592 | 3.0 | CHARACTER | |||||||
| PET imaging agent source | PET Imaging Agent Source Type | 2718368 | 3.0 | CHARACTER | |||||||
| Obtained from outside supplier | Obtained from outside supplier | The radiosotope is obtained from a supplier that attests that its production of FDG is compliant with relevant USP standards | |||||||||
| Prepared in-house | Prepared in-house | The radioisotope is manufactured on site and the site attests that its production is compliant with relevant USP standards. | |||||||||
| Purchased | Purchased | FDG is obtained from a supplier that attests that its production of FDG is compliant with relevant USP standards. | |||||||||
| Synthesized | Synthesized | FDG is manufactured on site and the site attests that its production is compliant with relevant USP standards. | |||||||||
| Was imaging agent administered? | Imaging Agent Administered Yes No Indicator | 3165845 | 1.0 | CHARACTER | |||||||
| Yes | Yes | The affirmative response to a question or activity. | |||||||||
| No | No | The non-affirmative response to a question. | |||||||||
| Date Agent Administered | Agent Administered Date | 2006399 | 4.0 | DATE | MM/DD/YYYY | ||||||
| Route of Administration | Agent Administration Type | 62589 | 6.0 | CHARACTER | |||||||
| Pill | Pill | Pill or tablet | |||||||||
| Bolus injection | Bolus injection | Bolus injection | |||||||||
| IM | INTRAMUSCULAR ADMINISTRATION OF DRUG | INTRAMUSCULAR ADMINISTRATION OF DRUG | |||||||||
| Infusion | INFUSION | INFUSION | |||||||||
| Inhaled | Inhalation Route of Administration | Administration 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. | |||||||||
| injection/implant | injection/transdermal | injection/transdermal | |||||||||
| Intramuscular | Intramuscular | Intramuscular | |||||||||
| IV | INTRAVENOUS ADMINISTRATION OF DRUG | INTRAVENOUS ADMINISTRATION OF DRUG | |||||||||
| nasal | nasal route of administration | Administration 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. | |||||||||
| Ocular | OCULAR | OCULAR | |||||||||
| oral | ORAL ADMINISTRATION OF DRUG | ORAL ADMINISTRATION OF DRUG | |||||||||
| Other | Other | Not otherwise specified. | |||||||||
| PO | ORAL ADMINISTRATION OF DRUG | ORAL ADMINISTRATION OF DRUG | |||||||||
| Subcutaneous | Subcutaneous | Subcutaneous | |||||||||
| transdermal/topical | NDC TRANSDERMAL - 358 | NDC TRANSDERMAL - 358 | |||||||||
| vaginal | vaginal route of administration | Administration 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 Site | PET Isotope Injection Anatomic Site Code | 2714760 | 2.0 | CHARACTER | |||||||
| 1 | Right antecubital | Right antecubital | |||||||||
| 2 | Right wrist | Right wrist | |||||||||
| 3 | Left antecubital | Left antecubital | |||||||||
| 4 | Left wrist | Left wrist | |||||||||
| 5 | Right foot | Right foot | |||||||||
| 6 | Left foot | Left foot | |||||||||
| 88 | Other, specify | Other, specify | |||||||||
| 99 | Unknown | Not known, not observed, not recorded, or refused. | |||||||||
| Location of injection site, Other specify | PET Isotope Injection Other Specify | 2714877 | 1.0 | CHARACTER | |||||||
| Activity in full syringe before injection | PET Isotope Begin Dose Assay Value | 2732417 | 2.0 | NUMBER | mCi | ||||||
| Time of assay of full syringe before injection | PET Isotope Begin Dose Assay Time | 2716598 | 1.0 | TIME | TIME (HR(24):MN) | ||||||
| Time of injection | PET Isotope Injection Start Time | 2716600 | 1.0 | TIME | TIME (HR(24):MN) | ||||||
| Residual activity in syringe after injection | PET Isotope Residual Dose Assay Isotope Value | 2716774 | 2.0 | NUMBER | mCi | ||||||
| Time of assay of residual activity after injection | PET Isotope Residual Dose Assay Time | 2716772 | 1.0 | TIME | TIME (HR(24):MN) | ||||||
| Net activity at the time of injection | PET Isotope Injection Time Dose Assay Value | 3419986 | 1.0 | NUMBER | mCi | ||||||
| Any imaging agent infiltration at injection site noted? | PET Isotope Infiltration Infiltration Type | 2716522 | 2.0 | CHARACTER | |||||||
| Minor (<= 20% of dose) | Minor infiltration is estimated to be less than or equal to 20% of dose | Minor infiltration is estimated to be less than or equal to 20% of dose | |||||||||
| None | No infiltration of radiotracer | No infiltration of radiotracer | |||||||||
| Severe (> 20% of dose) | Severe infiltration is estimated to be more than 20% of dose | Severe infiltration is estimated to be more than 20% of dose | |||||||||
| PET imaging agent name | PET Imaging Agent Identifier Name | 3165834 | 2.0 | CHARACTER | |||||||
| Cu-64 ATSM | Cu-64 ATSM | Cu-64 ATSM | |||||||||
| F-18 FDG | F-18 FDG | F-18 FDG | |||||||||
| F-18 FLT | F-18 FLT | F-18 FLT | |||||||||
| F-18 Fluoride | F-18 Fluoride | F-18 Fluoride | |||||||||
| F-18 Fluorodihydrotestosterone (FDHT) | F-18 Fluorodihydrotestosterone (FDHT) | F-18 Fluorodihydrotestosterone (FDHT) | |||||||||
| F-18 Fluorodopa | F-18 Fluorodopa | F-18 Fluorodopa | |||||||||
| F-18 Fluoroestradiol (FES) | F-18 Fluoroestradiol (FES) | F-18 Fluoroestradiol (FES) | |||||||||
| F-18 FMISO | F-18 FMISO | F-18 FMISO | |||||||||
| Ga-68 DOTA-NOC | Ga-68 DOTA-NOC | Ga-68 DOTA-NOC | |||||||||
| Ga-68 DOTATOC | Ga-68 DOTATOC | Ga-68 DOTATOC | |||||||||
| I -124 Iodide | I -124 Iodide | I -124 Iodide | |||||||||
| Confirmed patient with no allergy to contrast agent prior to administration | IV Contrast No Allergy Confirmation Prior Administer Yes No Indicator | 3915791 | 1.0 | CHARACTER | |||||||
| Yes | Yes | The affirmative response to a question or activity. | |||||||||
| No | No | The non-affirmative response to a question. | |||||||||
| Conditional PET Imaging Agent Question | There are business rules to indicate situations under which these elements should be used on a case report form. | ||||||||||
| Supplier | Agent Supplier Name | 2971977 | 1.0 | CHARACTER | |||||||
| Optional PET Imaging Agent Questions | There 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. | ||||||||||
| Method [of synthesis] | PET Imaging Agent Manufactured Method Text | 3165839 | 1.0 | CHARACTER | |||||||
| Net activity at time of assay | PET Isotope Time Dose Assay Value | 3419980 | 1.0 | NUMBER | mCi | ||||||
| Pyrogen test results | PET Imaging Agent Pyrogen Test Result Type | 3165865 | 1.0 | CHARACTER | |||||||
| Failed | Failed | Failed test | |||||||||
| Not Done | Not Done | Testing not done | |||||||||
| Passed | Passed | Passed test | |||||||||
| Radiochemical purity test result | PET Imaging Agent Radiopharmaceutical Purity Test Result Number | 3165873 | 1.0 | CHARACTER | |||||||
| Specific Activity | Imaging Agent Radionuclide Specific Activity Value | 3930171 | 1.0 | NUMBER | mCi/g |
