ID

35014

Description

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

Lien

https://clinicaltrials.gov/show/NCT02380209

Mots-clés

  1. 09/02/2019 09/02/2019 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

9 février 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT02380209

Eligibility Breast Cancer NCT02380209

Inclusion Criteria
Description

Inclusion Criteria

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

Invasive Ductal Breast Carcinoma

Type de données

boolean

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

Primary tumor Size

Type de données

boolean

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

Estimation of creatinine clearance by Cockcroft-Gault formula

Type de données

boolean

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

Informed Consent

Type de données

boolean

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

Age

Type de données

boolean

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

ECOG performance status

Type de données

boolean

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

Patient Information Study Protocol

Type de données

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergy to iodinated contrast agent
Description

Hypersensitivity Iodinated contrast dye

Type de données

boolean

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

Metformin | Aminoglycosides | Pharmaceutical Preparations Nephrotoxic | NSAIDs Daily

Type de données

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
Description

Diabetes Mellitus

Type de données

boolean

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

Claustrophobia Severe

Type de données

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
Description

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

Type de données

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
Description

Antihypertensive Agents Quantity

Type de données

boolean

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

Pregnancy | Breast Feeding

Type de données

boolean

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

Paraproteinemias | Multiple Myeloma

Type de données

boolean

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

Collagen-vascular disease

Type de données

boolean

Alias
UMLS CUI [1]
C0262428
active hyperthyroidism
Description

Hyperthyroidism

Type de données

boolean

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

Pharmacotherapy Malignant Neoplasms

Type de données

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)
Type de données
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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