ID

35014

Beschrijving

An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02380209

Link

https://clinicaltrials.gov/show/NCT02380209

Trefwoorden

  1. 09-02-19 09-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

9 februari 2019

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT02380209

Eligibility Breast Cancer NCT02380209

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed infiltrating ductal carcinoma (idc) of the breast
Beschrijving

Invasive Ductal Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C1134719
>= 1.0 cm primary tumor
Beschrijving

Primary tumor Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C0456389
calculated creatinine clearance >= 50 ml/min
Beschrijving

Estimation of creatinine clearance by Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1]
C2711451
willing and able to provide informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
age ≥ 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
informed of the investigational nature of this study
Beschrijving

Patient Information Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1955348
UMLS CUI [1,2]
C2348563
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergy to iodinated contrast agent
Beschrijving

Hypersensitivity Iodinated contrast dye

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0879373
use of metformin, aminoglycosides, other nephrotoxic medications, or daily use of nsaids
Beschrijving

Metformin | Aminoglycosides | Pharmaceutical Preparations Nephrotoxic | NSAIDs Daily

Datatype

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0002556
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C1514118
UMLS CUI [4,1]
C0003211
UMLS CUI [4,2]
C0332173
diabetes mellitus
Beschrijving

Diabetes Mellitus

Datatype

boolean

Alias
UMLS CUI [1]
C0011849
history of severe claustrophobia
Beschrijving

Claustrophobia Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0205082
presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude mri
Beschrijving

Implants Exclude MRI | Artificial cardiac pacemaker | Cochlear Implants | Surgical Clips Magnetic | Prosthesis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0009199
UMLS CUI [4,1]
C0038917
UMLS CUI [4,2]
C0563532
UMLS CUI [5]
C0175649
use of > 1 antihypertensive drug
Beschrijving

Antihypertensive Agents Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
pregnancy or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
paraproteinemia syndromes or multiple myeloma
Beschrijving

Paraproteinemias | Multiple Myeloma

Datatype

boolean

Alias
UMLS CUI [1]
C0030489
UMLS CUI [2]
C0026764
collagen vascular disease
Beschrijving

Collagen-vascular disease

Datatype

boolean

Alias
UMLS CUI [1]
C0262428
active hyperthyroidism
Beschrijving

Hyperthyroidism

Datatype

boolean

Alias
UMLS CUI [1]
C0020550
active pharmaceutical treatments for cancer
Beschrijving

Pharmacotherapy Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0006826

Similar models

Eligibility Breast Cancer NCT02380209

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Invasive Ductal Breast Carcinoma
Item
newly diagnosed infiltrating ductal carcinoma (idc) of the breast
boolean
C1134719 (UMLS CUI [1])
Primary tumor Size
Item
>= 1.0 cm primary tumor
boolean
C0677930 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
calculated creatinine clearance >= 50 ml/min
boolean
C2711451 (UMLS CUI [1])
Informed Consent
Item
willing and able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Patient Information Study Protocol
Item
informed of the investigational nature of this study
boolean
C1955348 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Iodinated contrast dye
Item
allergy to iodinated contrast agent
boolean
C0020517 (UMLS CUI [1,1])
C0879373 (UMLS CUI [1,2])
Metformin | Aminoglycosides | Pharmaceutical Preparations Nephrotoxic | NSAIDs Daily
Item
use of metformin, aminoglycosides, other nephrotoxic medications, or daily use of nsaids
boolean
C0025598 (UMLS CUI [1])
C0002556 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C1514118 (UMLS CUI [3,2])
C0003211 (UMLS CUI [4,1])
C0332173 (UMLS CUI [4,2])
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Claustrophobia Severe
Item
history of severe claustrophobia
boolean
C0008909 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Implants Exclude MRI | Artificial cardiac pacemaker | Cochlear Implants | Surgical Clips Magnetic | Prosthesis
Item
presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude mri
boolean
C0021102 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0030163 (UMLS CUI [2])
C0009199 (UMLS CUI [3])
C0038917 (UMLS CUI [4,1])
C0563532 (UMLS CUI [4,2])
C0175649 (UMLS CUI [5])
Antihypertensive Agents Quantity
Item
use of > 1 antihypertensive drug
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Paraproteinemias | Multiple Myeloma
Item
paraproteinemia syndromes or multiple myeloma
boolean
C0030489 (UMLS CUI [1])
C0026764 (UMLS CUI [2])
Collagen-vascular disease
Item
collagen vascular disease
boolean
C0262428 (UMLS CUI [1])
Hyperthyroidism
Item
active hyperthyroidism
boolean
C0020550 (UMLS CUI [1])
Pharmacotherapy Malignant Neoplasms
Item
active pharmaceutical treatments for cancer
boolean
C0013216 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])

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