ID

28359

Descrição

Health Economic Evaluation of Primovist-enhanced Liver MRI; ODM derived from: https://clinicaltrials.gov/show/NCT00764621

Link

https://clinicaltrials.gov/show/NCT00764621

Palavras-chave

Versões (1)
  1. 07/01/2018 07/01/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de janeiro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT00764621

Inglês

Eligibility Colorectal Neoplasms NCT00764621

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging
Descrição

Secondary malignant neoplasm of liver Secondary to Colorectal Carcinoma | Secondary malignant neoplasm of liver Suspected Secondary to Colorectal Carcinoma | Contrast Enhanced CT Scheduled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0494165
UMLS CUI [1,2]
C0175668
UMLS CUI [1,3]
C0009402
UMLS CUI [2,1]
C0494165
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0175668
UMLS CUI [2,4]
C0009402
UMLS CUI [3,1]
C1512095
UMLS CUI [3,2]
C0205539
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients (men or women) under 18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
patients who have received any contrast material within 24 hours before injection of study drug, or who are scheduled to receive any contrast material within 24 hours after injection
Descrição

Contrast Media Received | Contrast Media Scheduled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009924
UMLS CUI [1,2]
C1514756
UMLS CUI [2,1]
C0009924
UMLS CUI [2,2]
C0205539
patients not eligible to contrast media (cm) injection according to product labeling
Descrição

Ineligibility Contrast Media Injection

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0009924
UMLS CUI [1,3]
C1533685
women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test at baseline visit(s)
Descrição

Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test negative Lacking

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430057
UMLS CUI [3,3]
C0332268
patients scheduled for liver-specific mri other than primovist-enhanced mri, i.e. multihance-, teslascan- or spio-enhanced mri
Descrição

MRI of Liver Scheduled | Exception MRI Eovist Enhanced | Exception MRI MultiHance Enhanced | Exception MRI Teslascan Enhanced | Exception SPIO-MRI

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0412694
UMLS CUI [1,2]
C0205539
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0024485
UMLS CUI [2,3]
C0675788
UMLS CUI [2,4]
C2349975
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0024485
UMLS CUI [3,3]
C0753357
UMLS CUI [3,4]
C2349975
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0024485
UMLS CUI [4,3]
C0637607
UMLS CUI [4,4]
C2349975
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C3896586
patients who are clinically unstable and whose clinical course is unpredictable (e.g. due to previous surgery, acute myocardial infarction)
Descrição

Patients Unstable Due to Operative Surgical Procedures | Patients Unstable Due to Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0543467
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0443343
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0027051
patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs
Descrição

Anaphylactoid reaction Contrast Media | Anaphylaxis Contrast Media | Drug Allergy Allergen

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0340865
UMLS CUI [1,2]
C0009924
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0009924
UMLS CUI [3]
C1548333
patients with a contraindication for mri or ct.
Descrição

Medical contraindication MRI | Medical contraindication CT

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0040405
patients with severe renal impairment (egfr < 30ml/min/1.73m2) or patients on dialysis
Descrição

Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Dialysis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
UMLS CUI [3]
C0011946
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Similar models

Eligibility Colorectal Neoplasms NCT00764621

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of liver Secondary to Colorectal Carcinoma | Secondary malignant neoplasm of liver Suspected Secondary to Colorectal Carcinoma | Contrast Enhanced CT Scheduled
Item
patients with known or suspected metachronous liver metastases secondary to colorectal cancer who are scheduled for further contrast-enhanced tomographic imaging
boolean
C0494165 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
C0494165 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0175668 (UMLS CUI [2,3])
C0009402 (UMLS CUI [2,4])
C1512095 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients (men or women) under 18 years of age
boolean
C0001779 (UMLS CUI [1])
Contrast Media Received | Contrast Media Scheduled
Item
patients who have received any contrast material within 24 hours before injection of study drug, or who are scheduled to receive any contrast material within 24 hours after injection
boolean
C0009924 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0009924 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Ineligibility Contrast Media Injection
Item
patients not eligible to contrast media (cm) injection according to product labeling
boolean
C1512714 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
C1533685 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Childbearing Potential Urine pregnancy test negative Lacking
Item
women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test at baseline visit(s)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430057 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
MRI of Liver Scheduled | Exception MRI Eovist Enhanced | Exception MRI MultiHance Enhanced | Exception MRI Teslascan Enhanced | Exception SPIO-MRI
Item
patients scheduled for liver-specific mri other than primovist-enhanced mri, i.e. multihance-, teslascan- or spio-enhanced mri
boolean
C0412694 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0675788 (UMLS CUI [2,3])
C2349975 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C0753357 (UMLS CUI [3,3])
C2349975 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0637607 (UMLS CUI [4,3])
C2349975 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C3896586 (UMLS CUI [5,2])
Patients Unstable Due to Operative Surgical Procedures | Patients Unstable Due to Myocardial Infarction
Item
patients who are clinically unstable and whose clinical course is unpredictable (e.g. due to previous surgery, acute myocardial infarction)
boolean
C0030705 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0027051 (UMLS CUI [2,4])
Anaphylactoid reaction Contrast Media | Anaphylaxis Contrast Media | Drug Allergy Allergen
Item
patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs
boolean
C0340865 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0009924 (UMLS CUI [2,2])
C1548333 (UMLS CUI [3])
Medical contraindication MRI | Medical contraindication CT
Item
patients with a contraindication for mri or ct.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate | Dialysis
Item
patients with severe renal impairment (egfr < 30ml/min/1.73m2) or patients on dialysis
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
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