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

Link

https://clinicaltrials.gov/show/NCT02380209

Keywords

Versions (1)
  1. 2/9/19 2/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02380209

English

Eligibility Breast Cancer NCT02380209

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Invasive Ductal Breast Carcinoma

Data type

boolean

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

Primary tumor Size

Data type

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

Data type

boolean

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

Informed Consent

Data type

boolean

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

Age

Data type

boolean

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

ECOG performance status

Data type

boolean

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

Patient Information Study Protocol

Data type

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

Data type

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

Data type

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

Data type

boolean

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

Claustrophobia Severe

Data type

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

Data type

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

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Paraproteinemias | Multiple Myeloma

Data type

boolean

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

Collagen-vascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0262428
active hyperthyroidism
Description

Hyperthyroidism

Data type

boolean

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

Pharmacotherapy Malignant Neoplasms

Data type

boolean

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

Eligibility Breast Cancer NCT02380209

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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