ID

41194

Beschrijving

Evaluation of 4D-contrast Enhanced PET-CT in Tumour Volume Definition; ODM derived from: https://clinicaltrials.gov/show/NCT02285660

Link

https://clinicaltrials.gov/show/NCT02285660

Trefwoorden

Versies (1)
  1. 10-07-20 10-07-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 juli 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Lung Carcinoma NCT02285660

Engels

Eligibility Lung Carcinoma NCT02285660

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
who performance status 02 (appendix a)
Beschrijving

WHO performance status scale

Datatype

boolean

Alias
UMLS CUI [1]
C1298650
histologically proven non small cell lung carcinoma, distal oesophageal carcinoma or pancreatic adenocarcinoma
Beschrijving

Non-Small Cell Lung Carcinoma | Esophageal carcinoma Distal | Adenocarcinoma of pancreas

Datatype

boolean

Alias
UMLS CUI [1]
C0007131
UMLS CUI [2,1]
C0152018
UMLS CUI [2,2]
C0205108
UMLS CUI [3]
C0281361
clinical decision made to proceed with a course of radiotherapy of curative intent with or without concurrent chemotherapy
Beschrijving

Therapeutic radiology procedure Curative | Chemotherapy | Chemotherapy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1276305
UMLS CUI [2]
C0392920
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332197
measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging
Beschrijving

Primary Neoplasm Measurable | Secondary malignant neoplasm of lymph node Locoregional Imaging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C1513040
UMLS CUI [2,1]
C0686619
UMLS CUI [2,2]
C1947913
UMLS CUI [2,3]
C0011923
able to provide fully informed written consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
able to lie flat for 1 hour
Beschrijving

Able to lie down Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C0560841
UMLS CUI [1,2]
C0449238
not be pregnant or breast feeding. female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal.
Beschrijving

Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Contraceptive methods | Female Sterilization | Postmenopausal state

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0015787
UMLS CUI [5]
C0232970
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. hypersensitivity to fluorine18 fludeoxyglucose (fdg)
Beschrijving

Hypersensitivity Fluorodeoxyglucose F18

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0046056
2. hypersensitivity to iodinated contrast media
Beschrijving

Hypersensitivity Iodinated contrast media

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1960405
3. poorly controlled diabetes
Beschrijving

Poorly controlled diabetes mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0554876
4. acute renal failure or moderate renal impairment (estimated glomerular filtration rate < 30 ml/min)
Beschrijving

Kidney Failure | Renal Insufficiency Moderate | Estimated Glomerular Filtration Rate

Datatype

boolean

Alias
UMLS CUI [1]
C0035078
UMLS CUI [2,1]
C1565489
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C3811844
5. claustrophobia precluding imaging
Beschrijving

Claustrophobia Excludes Imaging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0011923
6. uncontrolled pain
Beschrijving

Uncontrolled pain

Datatype

boolean

Alias
UMLS CUI [1]
C0747149
7. urinary incontinence
Beschrijving

Urinary Incontinence

Datatype

boolean

Alias
UMLS CUI [1]
C0042024
8. female patients must not be pregnant and if of child bearing age using adequate contraception
Beschrijving

Pregnancy | Childbearing Potential Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
9. breast feeding
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
10. serious psychiatric comorbidity
Beschrijving

Comorbidity Serious Psychiatric

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205487
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Similar models

Eligibility Lung Carcinoma NCT02285660

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥18
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
who performance status 02 (appendix a)
boolean
C1298650 (UMLS CUI [1])
Non-Small Cell Lung Carcinoma | Esophageal carcinoma Distal | Adenocarcinoma of pancreas
Item
histologically proven non small cell lung carcinoma, distal oesophageal carcinoma or pancreatic adenocarcinoma
boolean
C0007131 (UMLS CUI [1])
C0152018 (UMLS CUI [2,1])
C0205108 (UMLS CUI [2,2])
C0281361 (UMLS CUI [3])
Therapeutic radiology procedure Curative | Chemotherapy | Chemotherapy Absent
Item
clinical decision made to proceed with a course of radiotherapy of curative intent with or without concurrent chemotherapy
boolean
C1522449 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Primary Neoplasm Measurable | Secondary malignant neoplasm of lymph node Locoregional Imaging
Item
measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging
boolean
C0677930 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0686619 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
Informed Consent
Item
able to provide fully informed written consent
boolean
C0021430 (UMLS CUI [1])
Able to lie down Duration
Item
able to lie flat for 1 hour
boolean
C0560841 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Contraceptive methods | Female Sterilization | Postmenopausal state
Item
not be pregnant or breast feeding. female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0015787 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Fluorodeoxyglucose F18
Item
1. hypersensitivity to fluorine18 fludeoxyglucose (fdg)
boolean
C0020517 (UMLS CUI [1,1])
C0046056 (UMLS CUI [1,2])
Hypersensitivity Iodinated contrast media
Item
2. hypersensitivity to iodinated contrast media
boolean
C0020517 (UMLS CUI [1,1])
C1960405 (UMLS CUI [1,2])
Poorly controlled diabetes mellitus
Item
3. poorly controlled diabetes
boolean
C0554876 (UMLS CUI [1])
Kidney Failure | Renal Insufficiency Moderate | Estimated Glomerular Filtration Rate
Item
4. acute renal failure or moderate renal impairment (estimated glomerular filtration rate < 30 ml/min)
boolean
C0035078 (UMLS CUI [1])
C1565489 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3811844 (UMLS CUI [3])
Claustrophobia Excludes Imaging
Item
5. claustrophobia precluding imaging
boolean
C0008909 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
Uncontrolled pain
Item
6. uncontrolled pain
boolean
C0747149 (UMLS CUI [1])
Urinary Incontinence
Item
7. urinary incontinence
boolean
C0042024 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods
Item
8. female patients must not be pregnant and if of child bearing age using adequate contraception
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Breast Feeding
Item
9. breast feeding
boolean
C0006147 (UMLS CUI [1])
Comorbidity Serious Psychiatric
Item
10. serious psychiatric comorbidity
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205487 (UMLS CUI [1,3])
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