ID

14795

Description

SentiMag® Intraoperative Comparison in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02336737

Link

https://clinicaltrials.gov/show/NCT02336737

Keywords

Versions (1)
  1. 4/28/16 4/28/16 -
Uploaded on

April 28, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02336737

English

Eligibility Breast Cancer NCT02336737

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (dcis).
Description

Breast Carcinoma Primary | Noninfiltrating Intraductal Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C0007124
subjects scheduled for surgical intervention, with a sentinel lymph node biopsy procedure being a part of the surgical plan.
Description

Scheduled - procedure status Surgical/procedural intervention Sentinel Lymph Node Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0205539
UMLS CUI [1,2]
C4035998
UMLS CUI [1,3]
C0796693
subjects aged 18 years or more at the time of consent.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects with an ecog (eastern cooperative oncology group) performance status of grade 0 - 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
subject has a clinical negative node status (i.e. t0-3, n0, m0).
Description

malignant neoplasm of breast staging

Data type

boolean

Alias
UMLS CUI [1]
C2216702
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject is pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
the subject has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes.
Description

Neoplasm Metastasis Lymph nodes scan abnormal

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0855968
the subject has a known hypersensitivity to isosulfan blue dye.
Description

Hypersensitivity iso-sulfan blue

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0063908
the subject has participated in another investigational drug study within 30 days of scheduled surgery.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c) lymphatic function that is impaired in the surgeon's judgment.
Description

Operative Surgical Procedures Axilla | Reduction mammaplasty | Lymphatic System Function Impaired

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0004454
UMLS CUI [2]
C0191922
UMLS CUI [3,1]
C0024235
UMLS CUI [3,2]
C0542341
UMLS CUI [3,3]
C0221099
subject has had preoperative radiation therapy to the affected breast or axilla.
Description

Therapeutic radiology procedure Preoperative | Female breast | Axilla

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0445204
UMLS CUI [2]
C0222603
UMLS CUI [3]
C0004454
subject has received a feraheme® (ferumoxytol) injection within the past 6 months.
Description

Feraheme Ferumoxytol Injectable Solution

Data type

boolean

Alias
UMLS CUI [1,1]
C2718747
UMLS CUI [1,2]
C2709673
subject has intolerance or hypersensitivity to iron or dextran compounds or to siennaxp.
Description

intolerance to Iron Compounds | intolerance to Dextran Compound | Hypersensitivity Iron Compounds | Hypersensitivity Dextran Compound

Data type

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0684279
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0086140
UMLS CUI [2,3]
C1706082
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0684279
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0086140
UMLS CUI [4,3]
C1706082
subject has an iron overload disease.
Description

Iron Overload

Data type

boolean

Alias
UMLS CUI [1]
C0282193
subject has pacemaker or other implantable device in the chest wall.
Description

Artificial cardiac pacemaker Chest wall | Implants Chest wall

Data type

boolean

Alias
UMLS CUI [1,1]
C0030163
UMLS CUI [1,2]
C1279035
UMLS CUI [2,1]
C0021102
UMLS CUI [2,2]
C1279035
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Similar models

Eligibility Breast Cancer NCT02336737

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma Primary | Noninfiltrating Intraductal Carcinoma
Item
subjects with a diagnosis of primary breast cancer or subjects with pure ductal carcinoma in situ (dcis).
boolean
C0678222 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2])
Scheduled - procedure status Surgical/procedural intervention Sentinel Lymph Node Biopsy
Item
subjects scheduled for surgical intervention, with a sentinel lymph node biopsy procedure being a part of the surgical plan.
boolean
C0205539 (UMLS CUI [1,1])
C4035998 (UMLS CUI [1,2])
C0796693 (UMLS CUI [1,3])
Age
Item
subjects aged 18 years or more at the time of consent.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
subjects with an ecog (eastern cooperative oncology group) performance status of grade 0 - 2.
boolean
C1520224 (UMLS CUI [1])
malignant neoplasm of breast staging
Item
subject has a clinical negative node status (i.e. t0-3, n0, m0).
boolean
C2216702 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
the subject is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Neoplasm Metastasis Lymph nodes scan abnormal
Item
the subject has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes.
boolean
C0027627 (UMLS CUI [1,1])
C0855968 (UMLS CUI [1,2])
Hypersensitivity iso-sulfan blue
Item
the subject has a known hypersensitivity to isosulfan blue dye.
boolean
C0020517 (UMLS CUI [1,1])
C0063908 (UMLS CUI [1,2])
Study Subject Participation Status
Item
the subject has participated in another investigational drug study within 30 days of scheduled surgery.
boolean
C2348568 (UMLS CUI [1])
Operative Surgical Procedures Axilla | Reduction mammaplasty | Lymphatic System Function Impaired
Item
subject has had either a) previous axilla surgery, b) reduction mammoplasty, or c) lymphatic function that is impaired in the surgeon's judgment.
boolean
C0543467 (UMLS CUI [1,1])
C0004454 (UMLS CUI [1,2])
C0191922 (UMLS CUI [2])
C0024235 (UMLS CUI [3,1])
C0542341 (UMLS CUI [3,2])
C0221099 (UMLS CUI [3,3])
Therapeutic radiology procedure Preoperative | Female breast | Axilla
Item
subject has had preoperative radiation therapy to the affected breast or axilla.
boolean
C1522449 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0222603 (UMLS CUI [2])
C0004454 (UMLS CUI [3])
Feraheme Ferumoxytol Injectable Solution
Item
subject has received a feraheme® (ferumoxytol) injection within the past 6 months.
boolean
C2718747 (UMLS CUI [1,1])
C2709673 (UMLS CUI [1,2])
intolerance to Iron Compounds | intolerance to Dextran Compound | Hypersensitivity Iron Compounds | Hypersensitivity Dextran Compound
Item
subject has intolerance or hypersensitivity to iron or dextran compounds or to siennaxp.
boolean
C1744706 (UMLS CUI [1,1])
C0684279 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C0086140 (UMLS CUI [2,2])
C1706082 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0684279 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0086140 (UMLS CUI [4,2])
C1706082 (UMLS CUI [4,3])
Iron Overload
Item
subject has an iron overload disease.
boolean
C0282193 (UMLS CUI [1])
Artificial cardiac pacemaker Chest wall | Implants Chest wall
Item
subject has pacemaker or other implantable device in the chest wall.
boolean
C0030163 (UMLS CUI [1,1])
C1279035 (UMLS CUI [1,2])
C0021102 (UMLS CUI [2,1])
C1279035 (UMLS CUI [2,2])
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