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Long NameCT Imaging Agent NCI Standard Template
DefinitionThis module identifies mandatory and optional questions for use on electronic CRF when an imaging agent, or contrast, is used in the performance of Computed Tomography (CT) or Positron Emission Tomography/Computed Tomography (PET/CT).
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowDRAFT NEW
TypeCRF
Public ID3919982
Version1.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Optional Oral CT 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.
Oral contrast ingestedOral Contrast Agent Ingestion Code38673111.0CHARACTER
1NoThe non-affirmative response to a question.
2YesThe affirmative response to a question or activity.
If oral contrast was used, specify typeOral Contrast Agent Ingestion Type27260951.0CHARACTER
1Positive Contrast AgentContrast media that has a higher amplification and intensity than the surrounding tissue making the contrast look more opaque when seen in an x-ray.
2Negative Contrast AgentContrast media that has a lower amplification and intensity than the surrounding tissue making the contrast look less opaque when seen in an x-ray.
Oral contrast nameOral Contrast Agent Ingested Name38673511.0CHARACTER
Aromatase InhibitorAromatase InhibitorAn agent that blocks the function of the enzyme aromatase with antineoplastic activity. Aromatase inhibitors belong to two classes: Type I steroidal drugs are androgen substrate analogues that bind competitively but irreversibly to the enzyme. Type II nonsteroidal inhibitors fit into the substrate binding site and bind reversibly to the enzyme. Present in many tissues, aromatases are heme-containing enzymes that catalyze the adrenal conversion of cholesterol to pregnenolone and the peripheral conversion (aromatization) of androgenic precursors to estrogens. (NCI04)
Brentuximab VedotinBrentuximab VedotinAn antibody-drug conjugate (ADC) directed against the tumor necrosis factor (TNF) receptor CD30 with potential antineoplastic activity. Brentuximab vedotin is generated by conjugating the humanized anti-CD30 monoclonal antibody SGN-30 to the cytotoxic agent monomethyl auristatin E (MMAE) via a valine-citrulline peptide linker. Upon administration and internalization by CD30-positive tumor cells, brentuximab vedotin undergoes enzymatic cleavage, releasing MMAE into the cytosol; MMAE binds to tubulin and inhibits tubulin polymerization, which may result in G2/M phase arrest and tumor cell apoptosis. Transiently activated during lymphocyte activation, CD30 (tumor necrosis factor receptor superfamily, member 8;TNFRSF8) may be constitutively expressed in hematologic malignancies including Hodgkin lymphoma and some T-cell non-Hodgkin lymphomas. The linkage system in brentuximab vedotin is highly stable in plasma, resulting in cytotoxic specificity for CD30-positive cells.
BusulfanBusulfanA synthetic derivative of dimethane-sulfonate with antineoplastic and cytotoxic properties. Although its mechanism of action is not fully understood, busulfan appears to act through the alkylation of DNA. Following systemic absorption of busulfan, carbonium ions are formed, resulting in DNA alkylation and DNA breaks and inhibition of DNA replication and RNA transcription. (NCI04)
ch14.18Monoclonal Antibody Ch14.18A chimeric mouse/human monoclonal antibody with potential antineoplastic activity. Monoclonal antibody Ch14.18 binds to the ganglioside GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity against GD2-expressing tumor cells. GD2 is overexpressed in malignant melanoma, neuroblastoma, osteosarcoma, and small cell carcinoma of the lung. (NCI04)
CrizotinibCrizotinibAn orally available aminopyridine-based inhibitor of the receptor tyrosine kinase anaplastic lymphoma kinase (ALK) and the c-Met/hepatocyte growth factor receptor (HGFR) with antineoplastic activity. Crizotinib, in an ATP-competitive manner, binds to and inhibits ALK kinase and ALK fusion proteins. In addition, crizotinib inhibits c-Met kinase, and disrupts the c-Met signaling pathway. Altogether, this agent inhibits tumor cell growth. ALK belongs to the insulin receptor superfamily and plays an important role in nervous system development. ALK dysregulation and gene rearrangements are associated with a series of tumors.
CyclophosphamideCyclophosphamideA synthetic alkylating agent chemically related to the nitrogen mustards with antineoplastic and immunosuppressive activities. In the liver, cyclophosphamide is converted to the active metabolites aldophosphamide and phosphoramide mustard, which bind to DNA, thereby inhibiting DNA replication and initiating cell death. (NCI04)
DocetaxelDocetaxelA semi-synthetic, second-generation taxane derived from a compound found in the European yew tree, Taxus baccata. Docetaxel displays potent and broad antineoplastic properties; it binds to and stabilizes tubulin, thereby inhibiting microtubule disassembly which results in cell- cycle arrest at the G2/M phase and cell death. This agent also inhibits pro-angiogenic factors such as vascular endothelial growth factor (VEGF) and displays immunomodulatory and pro-inflammatory properties by inducing various mediators of the inflammatory response. Docetaxel has been studied for use as a radiation-sensitizing agent. (NCI04)
DoxorubicinDOXORUBICINDOXORUBICIN
EpirubicinEpirubicinA 4'-epi-isomer of the anthracycline antineoplastic antibiotic doxorubicin. Epirubicin intercalates into DNA and inhibits topoisomerase II, thereby inhibiting DNA replication and ultimately, interfering with RNA and protein synthesis. This agent also produces toxic free-radical intermediates and interacts with cell membrane lipids causing lipid peroxidation.
FECCyclophosphamide/Epirubicin/FluorouracilNo Value Exists
FluorouracilFluorouracilAn antimetabolite fluoropyrimidine analog of the nucleoside pyrimidine with antineoplastic activity. Fluorouracil and its metabolites possess a number of different mechanisms of action. In vivo, fluoruracil is converted to the active metabolite 5-fluoroxyuridine monophosphate (F-UMP); replacing uracil, F-UMP incorporates into RNA and inhibits RNA processing, thereby inhibiting cell growth. Another active metabolite, 5-5-fluoro-2'-deoxyuridine-5'-O-monophosphate (F-dUMP), inhibits thymidylate synthase, resulting in the depletion of thymidine triphosphate (TTP), a necessary constituent of DNA. Other fluorouracil metabolites incorporate into both RNA and DNA; incorporation into RNA results in major effects on both the processing and functions of RNA. (NCI04)
GM-CSFGM-CSFGranulocyte-macrophage colony-stimulating factor. A colony-stimulating factor that stimulates the production of white blood cells, especially granulocytes and macrophages, and cells (in the bone marrow) that are precursors of platelets. It is a cytokine that belongs to the family of drugs called hematopoietic (blood-forming) agents. Also called sargramostim.
IrinotecanIrinotecanA semisynthetic derivative of camptothecin, a cytotoxic, quinoline-based alkaloid extracted from the Asian tree Camptotheca acuminata. Irinotecan, a prodrug, is converted to a biologically active metabolite 7-ethyl-10-hydroxy-camptothecin (SN-38) by a carboxylesterase-converting enzyme. One thousand-fold more potent than its parent compound irinotecan, SN-38 inhibits topoisomerase I activity by stabilizing the cleavable complex between topoisomerase I and DNA, resulting in DNA breaks that inhibit DNA replication and trigger apoptotic cell death. Because ongoing DNA synthesis is necessary for irinotecan to exert its cytotoxic effects, it is classified as an S-phase-specific agent.
LHRH AgonistLHRH agonistLHRH agonist
MelphalanMelphalanAn orally available phenylalanine derivative of nitrogen mustard with antineoplastic activity. Melphalan alkylates DNA at the N7 position of guanine and induces DNA inter-strand cross-linkages, resulting in the inhibition of DNA and RNA synthesis and cytotoxicity against both dividing and non-dividing tumor cells. (NCI04)
OtherOtherNot otherwise specified.
PaclitaxelPaclitaxelA compound extracted from the Pacific yew tree Taxus brevifolia with antineoplastic activity. Paclitaxel binds to tubulin and inhibits the disassembly of microtubules, thereby resulting in the inhibition of cell division. This agent also induces apoptosis by binding to and blocking the function of the apoptosis inhibitor protein Bcl-2 (B-cell Leukemia 2). (NCI04)
TamoxifenTamoxifenAn antineoplastic nonsteroidal selective estrogen receptor modulator (SERM). Tamoxifen competitively inhibits the binding of estradiol to estrogen receptors, thereby preventing the receptor from binding to the estrogen-response element on DNA. The result is a reduction in DNA synthesis and cellular response to estrogen. In addition, tamoxifen up-regulates the production of transforming growth factor B (TGFb), a factor that inhibits tumor cell growth, and down-regulates insulin-like growth factor 1 (IGF-1), a factor that stimulates breast cancer cell growth. (NCI04)
TemozolomideTemozolomideA triazene analog of dacarbazine with antineoplastic activity. As a cytotoxic alkylating agent, temozolomide is converted at physiologic pH to the short-lived active compound, monomethyl triazeno imidazole carboxamide (MTIC). The cytotoxicity of MTIC is due primarily to methylation of DNA at the O6 and N7 positions of guanine, resulting in inhibition of DNA replication. Unlike dacarbazine, which is metabolized to MITC only in the liver, temozolomide is metabolized to MITC at all sites. Temozolomide is administered orally and penetrates well into the central nervous system. (NCI04)
TemsirolimusTemsirolimusAn ester analog of rapamycin. Temsirolimus binds to and inhibits the mammalian target of rapamycin (mTOR), resulting in decreased expression of mRNAs necessary for cell cycle progression and arresting cells in the G1 phase of the cell cycle. mTOR is a serine/threonine kinase which plays a role in the PI3K/AKT pathway that is upregulated in some tumors.
Concentration of oral contrast ingestedOral Contrast Agent Concentration 3 Digit Value38087491.0NUMBER
Amount of oral contrast ingestedOral Contrast Agent Ingested 4 Digit Value39081031.0NUMBER
Time oral contrast ingestedOral Contrast Agent Ingestion Time27183501.0TIMEhh:mm:ss
Conditional Intravenous CT Imaging Agent QuestionsThere are business rules to indicate situations under which these elements should be used on a case report form.
Any infiltration at injection site?Imaging Agent Infiltration Code38089771.0CHARACTER
1NoThe non-affirmative response to a question.
2YesThe affirmative response to a question or activity.
Optional Intravenous CT 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.
Pre-contrast administered?Imaging Pre Contrast Agent Code37934611.0CHARACTER
1NoThe non-affirmative response to a question.
2YesThe affirmative response to a question or activity.
IV contrast administeredIntravenous Contrast Agent Administered Code38673311.0CHARACTER
1NoThe non-affirmative response to a question.
2YesThe affirmative response to a question or activity.
IV contrast agent nameIntravenous Contrast Agent Administered Name38673321.0CHARACTER
Aromatase InhibitorAromatase InhibitorAn agent that blocks the function of the enzyme aromatase with antineoplastic activity. Aromatase inhibitors belong to two classes: Type I steroidal drugs are androgen substrate analogues that bind competitively but irreversibly to the enzyme. Type II nonsteroidal inhibitors fit into the substrate binding site and bind reversibly to the enzyme. Present in many tissues, aromatases are heme-containing enzymes that catalyze the adrenal conversion of cholesterol to pregnenolone and the peripheral conversion (aromatization) of androgenic precursors to estrogens. (NCI04)
Brentuximab VedotinBrentuximab VedotinAn antibody-drug conjugate (ADC) directed against the tumor necrosis factor (TNF) receptor CD30 with potential antineoplastic activity. Brentuximab vedotin is generated by conjugating the humanized anti-CD30 monoclonal antibody SGN-30 to the cytotoxic agent monomethyl auristatin E (MMAE) via a valine-citrulline peptide linker. Upon administration and internalization by CD30-positive tumor cells, brentuximab vedotin undergoes enzymatic cleavage, releasing MMAE into the cytosol; MMAE binds to tubulin and inhibits tubulin polymerization, which may result in G2/M phase arrest and tumor cell apoptosis. Transiently activated during lymphocyte activation, CD30 (tumor necrosis factor receptor superfamily, member 8;TNFRSF8) may be constitutively expressed in hematologic malignancies including Hodgkin lymphoma and some T-cell non-Hodgkin lymphomas. The linkage system in brentuximab vedotin is highly stable in plasma, resulting in cytotoxic specificity for CD30-positive cells.
BusulfanBusulfanA synthetic derivative of dimethane-sulfonate with antineoplastic and cytotoxic properties. Although its mechanism of action is not fully understood, busulfan appears to act through the alkylation of DNA. Following systemic absorption of busulfan, carbonium ions are formed, resulting in DNA alkylation and DNA breaks and inhibition of DNA replication and RNA transcription. (NCI04)
ch14.18Monoclonal Antibody Ch14.18A chimeric mouse/human monoclonal antibody with potential antineoplastic activity. Monoclonal antibody Ch14.18 binds to the ganglioside GD2 and induces antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity against GD2-expressing tumor cells. GD2 is overexpressed in malignant melanoma, neuroblastoma, osteosarcoma, and small cell carcinoma of the lung. (NCI04)
CrizotinibCrizotinibAn orally available aminopyridine-based inhibitor of the receptor tyrosine kinase anaplastic lymphoma kinase (ALK) and the c-Met/hepatocyte growth factor receptor (HGFR) with antineoplastic activity. Crizotinib, in an ATP-competitive manner, binds to and inhibits ALK kinase and ALK fusion proteins. In addition, crizotinib inhibits c-Met kinase, and disrupts the c-Met signaling pathway. Altogether, this agent inhibits tumor cell growth. ALK belongs to the insulin receptor superfamily and plays an important role in nervous system development. ALK dysregulation and gene rearrangements are associated with a series of tumors.
CyclophosphamideCyclophosphamideA synthetic alkylating agent chemically related to the nitrogen mustards with antineoplastic and immunosuppressive activities. In the liver, cyclophosphamide is converted to the active metabolites aldophosphamide and phosphoramide mustard, which bind to DNA, thereby inhibiting DNA replication and initiating cell death. (NCI04)
DocetaxelDocetaxelA semi-synthetic, second-generation taxane derived from a compound found in the European yew tree, Taxus baccata. Docetaxel displays potent and broad antineoplastic properties; it binds to and stabilizes tubulin, thereby inhibiting microtubule disassembly which results in cell- cycle arrest at the G2/M phase and cell death. This agent also inhibits pro-angiogenic factors such as vascular endothelial growth factor (VEGF) and displays immunomodulatory and pro-inflammatory properties by inducing various mediators of the inflammatory response. Docetaxel has been studied for use as a radiation-sensitizing agent. (NCI04)
DoxorubicinDOXORUBICINDOXORUBICIN
EpirubicinEpirubicinA 4'-epi-isomer of the anthracycline antineoplastic antibiotic doxorubicin. Epirubicin intercalates into DNA and inhibits topoisomerase II, thereby inhibiting DNA replication and ultimately, interfering with RNA and protein synthesis. This agent also produces toxic free-radical intermediates and interacts with cell membrane lipids causing lipid peroxidation.
FECCyclophosphamide/Epirubicin/FluorouracilNo Value Exists
FluorouracilFluorouracilAn antimetabolite fluoropyrimidine analog of the nucleoside pyrimidine with antineoplastic activity. Fluorouracil and its metabolites possess a number of different mechanisms of action. In vivo, fluoruracil is converted to the active metabolite 5-fluoroxyuridine monophosphate (F-UMP); replacing uracil, F-UMP incorporates into RNA and inhibits RNA processing, thereby inhibiting cell growth. Another active metabolite, 5-5-fluoro-2'-deoxyuridine-5'-O-monophosphate (F-dUMP), inhibits thymidylate synthase, resulting in the depletion of thymidine triphosphate (TTP), a necessary constituent of DNA. Other fluorouracil metabolites incorporate into both RNA and DNA; incorporation into RNA results in major effects on both the processing and functions of RNA. (NCI04)
GM-CSFGM-CSFGranulocyte-macrophage colony-stimulating factor. A colony-stimulating factor that stimulates the production of white blood cells, especially granulocytes and macrophages, and cells (in the bone marrow) that are precursors of platelets. It is a cytokine that belongs to the family of drugs called hematopoietic (blood-forming) agents. Also called sargramostim.
IrinotecanIrinotecanA semisynthetic derivative of camptothecin, a cytotoxic, quinoline-based alkaloid extracted from the Asian tree Camptotheca acuminata. Irinotecan, a prodrug, is converted to a biologically active metabolite 7-ethyl-10-hydroxy-camptothecin (SN-38) by a carboxylesterase-converting enzyme. One thousand-fold more potent than its parent compound irinotecan, SN-38 inhibits topoisomerase I activity by stabilizing the cleavable complex between topoisomerase I and DNA, resulting in DNA breaks that inhibit DNA replication and trigger apoptotic cell death. Because ongoing DNA synthesis is necessary for irinotecan to exert its cytotoxic effects, it is classified as an S-phase-specific agent.
LHRH AgonistLHRH agonistLHRH agonist
MelphalanMelphalanAn orally available phenylalanine derivative of nitrogen mustard with antineoplastic activity. Melphalan alkylates DNA at the N7 position of guanine and induces DNA inter-strand cross-linkages, resulting in the inhibition of DNA and RNA synthesis and cytotoxicity against both dividing and non-dividing tumor cells. (NCI04)
OtherOtherNot otherwise specified.
PaclitaxelPaclitaxelA compound extracted from the Pacific yew tree Taxus brevifolia with antineoplastic activity. Paclitaxel binds to tubulin and inhibits the disassembly of microtubules, thereby resulting in the inhibition of cell division. This agent also induces apoptosis by binding to and blocking the function of the apoptosis inhibitor protein Bcl-2 (B-cell Leukemia 2). (NCI04)
TamoxifenTamoxifenAn antineoplastic nonsteroidal selective estrogen receptor modulator (SERM). Tamoxifen competitively inhibits the binding of estradiol to estrogen receptors, thereby preventing the receptor from binding to the estrogen-response element on DNA. The result is a reduction in DNA synthesis and cellular response to estrogen. In addition, tamoxifen up-regulates the production of transforming growth factor B (TGFb), a factor that inhibits tumor cell growth, and down-regulates insulin-like growth factor 1 (IGF-1), a factor that stimulates breast cancer cell growth. (NCI04)
TemozolomideTemozolomideA triazene analog of dacarbazine with antineoplastic activity. As a cytotoxic alkylating agent, temozolomide is converted at physiologic pH to the short-lived active compound, monomethyl triazeno imidazole carboxamide (MTIC). The cytotoxicity of MTIC is due primarily to methylation of DNA at the O6 and N7 positions of guanine, resulting in inhibition of DNA replication. Unlike dacarbazine, which is metabolized to MITC only in the liver, temozolomide is metabolized to MITC at all sites. Temozolomide is administered orally and penetrates well into the central nervous system. (NCI04)
TemsirolimusTemsirolimusAn ester analog of rapamycin. Temsirolimus binds to and inhibits the mammalian target of rapamycin (mTOR), resulting in decreased expression of mRNAs necessary for cell cycle progression and arresting cells in the G1 phase of the cell cycle. mTOR is a serine/threonine kinase which plays a role in the PI3K/AKT pathway that is upregulated in some tumors.
IV contrast concentrationIntravenous Contrast Agent Concentration Value38087651.0NUMBERng/ml
Time IV contrast administeredIntravenous Contrast Agent Administered Time38673711.0TIMEhh:mm:ss
Location of Injection SiteIntravenous Contrast Agent Injection Anatomic Site Code38087961.0CHARACTER
1Right antecubitalBeing or located on or directed toward the side of the body to the east when facing north.: A triangular space on the anterior side of the elbow joint. Three main veins of the arm, the brachial artery, the medial nerve and the tendon of the biceps pass through this space.
2Right wristBeing or located on or directed toward the side of the body to the east when facing north.: The area of the body located between the antebrachial and metacarpal regions.
3Left antecubitalBeing or located on or directed toward the side of the body to the west when facing north.: A triangular space on the anterior side of the elbow joint. Three main veins of the arm, the brachial artery, the medial nerve and the tendon of the biceps pass through this space.
4Left wristBeing or located on or directed toward the side of the body to the west when facing north.: The area of the body located between the antebrachial and metacarpal regions.
5Right footBeing or located on or directed toward the side of the body to the east when facing north.: The terminal part of the lower extremity, especially the part below the ankle.
6Left footBeing or located on or directed toward the side of the body to the west when facing north.: The terminal part of the lower extremity, especially the part below the ankle.
88Other, specifyDifferent than the one(s) previously specified or mentioned.: Be specific about something; define clearly.: Named locations of, or within, the body.
99UnknownNot known, not observed, not recorded, or refused.
Type of Contrast Injector UsedImaging Agent Contrast Injector Type38089781.0CHARACTER
dual chamber power injectorDual Chamber Power InjectorA pump system with two enclosed reservoirs, designed to deliver various concentrations of intravenous contrast media.
dual chamber power injector with saline flushDual Chamber Power Injector With Saline FlushA pump system with two enclosed reservoirs, designed to deliver various concentrations of intravenous contrast media.: Used to indicate the presence of something or someone.: A saline solution used to force an agent from tubing and peripheral veins into the central blood volume.
single chamber power injectorSingle Chamber Power InjectorA pump system with one enclosed reservoir, designed to deliver intravenous contrast agent.
Flow RateIntravenous Contrast Agent Flow Rate Float39093491.0NUMBERcc/sec99.9
Was a test bolus performed?Intravenous Contrast Agent Test Bolus Infusion Performed Code38087701.0CHARACTER
1NoThe non-affirmative response to a question.
2YesThe affirmative response to a question or activity.
What type of contrast bolus was administrered?Intravenous Contrast Agent Bolus Infusion Administered Category38087751.0CHARACTER
BiphasicBiphasicOccurring in or characterized by two phases or stages.
MonophasicMonophasicOccurring in or characterized by only one phase or stage.
NoneNoneNo person or thing, nobody, not any.
TriphasicTriphasicOccurring in or characterized by three phases or stages.
Bolus Timing MethodIntravenous Contrast Agent Bolus Infusion Timing Method Category38087861.0CHARACTER
Auto-triggering usedAuto-triggered AdministeredActivation of a system without outside interference.: The act of having given something (e.g., a medication or test).
Fixed time delay [not recommended]Fix Time DelayCause to be firmly attached; stick or hold together and resist separation.: the continuum of experience in which events pass from the future through the present to the past.: Delay; time during which some action is awaited; inactivity resulting in something being put off until a later time.
Timing bolus usedTiming Bolus Infusion AdministeredThe chronological relationship between temporal events.: A single dose of drug usually injected into a blood vessel over a short period of time.: The act of having given something (e.g., a medication or test).
Amount of IV contrast injectedIntravenous Contrast Agent Dose38088031.0NUMBER