ID

35090

Description

Investigation of Diagnostic Improvement Gained Through Optimization of MR Methods for Breast Cancer Detection; ODM derived from: https://clinicaltrials.gov/show/NCT02411760

Link

https://clinicaltrials.gov/show/NCT02411760

Keywords

Versions (1)
  1. 2/15/19 2/15/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 15, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02411760

English

Eligibility Breast Neoplasms NCT02411760

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with breast imaging-reporting and data system (bi-rads) 4 or 5 age ≥ 18 years ability to understand and the willingness to sign a written informed consent.
Description

Gender | BIRADS | Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C1511314
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have had a needle biopsy of the suspicious area within the last 6 weeks subjects who have contraindication to contrast enhanced mri examination.
Description

Needle biopsy Area Suspicious | Medical contraindication Contrast-enhanced MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0005560
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C0750493
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1707501
contraindications to mri examinations include:
Description

Medical contraindications MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
medically unstable
Description

Unstable status Medical

Data type

boolean

Alias
UMLS CUI [1,1]
C0443343
UMLS CUI [1,2]
C0205476
heart failure
Description

Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
unstable angina
Description

Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0002965
child bearing
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
lactating any contraindication per mri screening form (appendix a attached).
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
implants contraindicated at 3t, pacemakers
Description

Implants | Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0021102
UMLS CUI [2]
C0030163
poorly controlled diabetes
Description

Poorly controlled diabetes mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0554876
body weight greater than 300 pounds
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
claustrophobic since each patient is receiving a gadolinium based contrast agent intravenously:
Description

Claustrophobia | Gadolinium-based Contrast Agent Intravenous

Data type

boolean

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2,1]
C3249258
UMLS CUI [2,2]
C1522726
egfr < 60 ml/min/1.73m2
Description

Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C3811844
sickle cell disease
Description

Sickle Cell Disease

Data type

boolean

Alias
UMLS CUI [1]
C0002895
hemolytic anemia
Description

Anemia, Hemolytic

Data type

boolean

Alias
UMLS CUI [1]
C0002878
subjects must not be pregnant or nursing due to the potential for gadolinium contrast agents to harm fetuses or nursing infants.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Neoplasms NCT02411760

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | BIRADS | Age | Informed Consent
Item
women with breast imaging-reporting and data system (bi-rads) 4 or 5 age ≥ 18 years ability to understand and the willingness to sign a written informed consent.
boolean
C0079399 (UMLS CUI [1])
C1511314 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0021430 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Needle biopsy Area Suspicious | Medical contraindication Contrast-enhanced MRI
Item
subjects who have had a needle biopsy of the suspicious area within the last 6 weeks subjects who have contraindication to contrast enhanced mri examination.
boolean
C0005560 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C0750493 (UMLS CUI [1,3])
C1301624 (UMLS CUI [2,1])
C1707501 (UMLS CUI [2,2])
Medical contraindications MRI
Item
contraindications to mri examinations include:
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Unstable status Medical
Item
medically unstable
boolean
C0443343 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
Heart failure
Item
heart failure
boolean
C0018801 (UMLS CUI [1])
Angina, Unstable
Item
unstable angina
boolean
C0002965 (UMLS CUI [1])
Pregnancy
Item
child bearing
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
lactating any contraindication per mri screening form (appendix a attached).
boolean
C0006147 (UMLS CUI [1])
Implants | Artificial cardiac pacemaker
Item
implants contraindicated at 3t, pacemakers
boolean
C0021102 (UMLS CUI [1])
C0030163 (UMLS CUI [2])
Poorly controlled diabetes mellitus
Item
poorly controlled diabetes
boolean
C0554876 (UMLS CUI [1])
Body Weight
Item
body weight greater than 300 pounds
boolean
C0005910 (UMLS CUI [1])
Claustrophobia | Gadolinium-based Contrast Agent Intravenous
Item
claustrophobic since each patient is receiving a gadolinium based contrast agent intravenously:
boolean
C0008909 (UMLS CUI [1])
C3249258 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
Estimated Glomerular Filtration Rate
Item
egfr < 60 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Sickle Cell Disease
Item
sickle cell disease
boolean
C0002895 (UMLS CUI [1])
Anemia, Hemolytic
Item
hemolytic anemia
boolean
C0002878 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
subjects must not be pregnant or nursing due to the potential for gadolinium contrast agents to harm fetuses or nursing infants.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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