ID

29271

Description

Digital Breast Tomosynthesis Versus Contrast Enhanced Magnetic Resonance Imaging (MRI) for Breast Cancer Staging; ODM derived from: https://clinicaltrials.gov/show/NCT01060085

Link

https://clinicaltrials.gov/show/NCT01060085

Keywords

Versions (1)
  1. 3/15/18 3/15/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 15, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Ductal Carcinoma In Situ NCT01060085

English

Eligibility Ductal Carcinoma In Situ NCT01060085

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is female of any race and ethnicity
Description

Gender | Racial group Any | Ethnicity Any

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0034510
UMLS CUI [2,2]
C1552551
UMLS CUI [3,1]
C0015031
UMLS CUI [3,2]
C1552551
subject is at least 30 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subject has histologically proven dcis or invasive breast carcinoma.
Description

Noninfiltrating Intraductal Carcinoma | Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2]
C0853879
subject is able to undergo cemri at dhmc-lebanon
Description

Contrast-enhanced Magnetic Resonance Imaging Medical center Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1707501
UMLS CUI [1,2]
C0565990
UMLS CUI [1,3]
C0205369
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who are pregnant or think they may be pregnant
Description

Pregnancy | Possible pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0425965
patients who are breast-feeding.
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
patients who have significant existing breast trauma
Description

Breast Trauma

Data type

boolean

Alias
UMLS CUI [1,1]
C0006141
UMLS CUI [1,2]
C3714660
subjects unable or unwilling to undergo informed consent
Description

Informed Consent Unable | Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
absolute contraindication to cemri, including:
Description

Medical contraindication Contrast-enhanced Magnetic Resonance Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1707501
1. presence of implanted electrical device (pacemaker or neurostimulator),aneurysm clip, or metallic foreign body in or near the eyes
Description

Implant Electrical | Artificial cardiac pacemaker | Neurostimulator | Aneurysm clip | Metallic foreign body Intraocular | Metallic foreign body Nearby Eye

Data type

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0442828
UMLS CUI [2]
C0030163
UMLS CUI [3]
C0582124
UMLS CUI [4]
C0179977
UMLS CUI [5,1]
C1720389
UMLS CUI [5,2]
C3282905
UMLS CUI [6,1]
C1720389
UMLS CUI [6,2]
C1706276
UMLS CUI [6,3]
C0015392
2. life threatening allergy to gadolinium contrast
Description

Hypersensitivity Life Threatening Gadolinium-based Contrast Agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2826244
UMLS CUI [1,3]
C3249258
cemri performed at institution other than dhmc lebanon
Description

Contrast-enhanced Magnetic Resonance Imaging Performed | Exception Medical center Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1707501
UMLS CUI [1,2]
C0884358
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0565990
UMLS CUI [2,3]
C0205369
patients undergoing neoadjuvant therapy
Description

Neoadjuvant Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0600558
patients with maximum tumor diameter >5cm
Description

Tumor Diameter Size Maximum

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0456389
UMLS CUI [1,4]
C0806909
patients presenting with inflammatory breast cancer
Description

Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0278601
patients with gross axillary lymphadenopathy on clinical exam or by imaging
Description

Axillary lymphadenopathy Gross Medical Examination | Axillary lymphadenopathy Gross Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0578735
UMLS CUI [1,2]
C0439806
UMLS CUI [1,3]
C0582103
UMLS CUI [2,1]
C0578735
UMLS CUI [2,2]
C0439806
UMLS CUI [2,3]
C0011923
maximum breast size limitation: i.e. breast size that exceeds the size of the large format image receptor (24cm x 29cm) on any view
Description

Breast Size Maximum Limitation

Data type

boolean

Alias
UMLS CUI [1,1]
C0425782
UMLS CUI [1,2]
C0806909
UMLS CUI [1,3]
C0449295
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Similar models

Eligibility Ductal Carcinoma In Situ NCT01060085

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Racial group Any | Ethnicity Any
Item
subject is female of any race and ethnicity
boolean
C0079399 (UMLS CUI [1])
C0034510 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C0015031 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
Age
Item
subject is at least 30 years old
boolean
C0001779 (UMLS CUI [1])
Noninfiltrating Intraductal Carcinoma | Invasive carcinoma of breast
Item
subject has histologically proven dcis or invasive breast carcinoma.
boolean
C0007124 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
Contrast-enhanced Magnetic Resonance Imaging Medical center Specified
Item
subject is able to undergo cemri at dhmc-lebanon
boolean
C1707501 (UMLS CUI [1,1])
C0565990 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Possible pregnancy
Item
patients who are pregnant or think they may be pregnant
boolean
C0032961 (UMLS CUI [1])
C0425965 (UMLS CUI [2])
Breast Feeding
Item
patients who are breast-feeding.
boolean
C0006147 (UMLS CUI [1])
Breast Trauma
Item
patients who have significant existing breast trauma
boolean
C0006141 (UMLS CUI [1,1])
C3714660 (UMLS CUI [1,2])
Informed Consent Unable | Informed Consent Unwilling
Item
subjects unable or unwilling to undergo informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Medical contraindication Contrast-enhanced Magnetic Resonance Imaging
Item
absolute contraindication to cemri, including:
boolean
C1301624 (UMLS CUI [1,1])
C1707501 (UMLS CUI [1,2])
Implant Electrical | Artificial cardiac pacemaker | Neurostimulator | Aneurysm clip | Metallic foreign body Intraocular | Metallic foreign body Nearby Eye
Item
1. presence of implanted electrical device (pacemaker or neurostimulator),aneurysm clip, or metallic foreign body in or near the eyes
boolean
C0021102 (UMLS CUI [1,1])
C0442828 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0582124 (UMLS CUI [3])
C0179977 (UMLS CUI [4])
C1720389 (UMLS CUI [5,1])
C3282905 (UMLS CUI [5,2])
C1720389 (UMLS CUI [6,1])
C1706276 (UMLS CUI [6,2])
C0015392 (UMLS CUI [6,3])
Hypersensitivity Life Threatening Gadolinium-based Contrast Agent
Item
2. life threatening allergy to gadolinium contrast
boolean
C0020517 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C3249258 (UMLS CUI [1,3])
Contrast-enhanced Magnetic Resonance Imaging Performed | Exception Medical center Specified
Item
cemri performed at institution other than dhmc lebanon
boolean
C1707501 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0565990 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Neoadjuvant Therapy
Item
patients undergoing neoadjuvant therapy
boolean
C0600558 (UMLS CUI [1])
Tumor Diameter Size Maximum
Item
patients with maximum tumor diameter >5cm
boolean
C0027651 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0806909 (UMLS CUI [1,4])
Inflammatory Breast Carcinoma
Item
patients presenting with inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
Axillary lymphadenopathy Gross Medical Examination | Axillary lymphadenopathy Gross Imaging
Item
patients with gross axillary lymphadenopathy on clinical exam or by imaging
boolean
C0578735 (UMLS CUI [1,1])
C0439806 (UMLS CUI [1,2])
C0582103 (UMLS CUI [1,3])
C0578735 (UMLS CUI [2,1])
C0439806 (UMLS CUI [2,2])
C0011923 (UMLS CUI [2,3])
Breast Size Maximum Limitation
Item
maximum breast size limitation: i.e. breast size that exceeds the size of the large format image receptor (24cm x 29cm) on any view
boolean
C0425782 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0449295 (UMLS CUI [1,3])
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