ID

35009

Beschrijving

Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma; ODM derived from: https://clinicaltrials.gov/show/NCT02316795

Link

https://clinicaltrials.gov/show/NCT02316795

Trefwoorden

Versies (1)
  1. 08-02-19 08-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02316795

Engels

Eligibility Breast Cancer NCT02316795

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed with clinically node-negative breast cancer or melanoma being staged with sln biopsy.
Beschrijving

Node-negative breast cancer Staging Sentinel Lymph Node Biopsy | Melanoma Staging Sentinel Lymph Node Biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3160889
UMLS CUI [1,2]
C0332305
UMLS CUI [1,3]
C0796693
UMLS CUI [2,1]
C0025202
UMLS CUI [2,2]
C0332305
UMLS CUI [2,3]
C0796693
negative nodal basin clinical exam.
Beschrijving

Lymphatic Basin Negative Clinical examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986565
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C1456356
at least 18 years of age.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
able to understand and willing to sign a written informed consent document.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
contraindications for surgery.
Beschrijving

Contraindication to surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0852649
receiving any investigational agents.
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
history of allergic reactions attributed to icg or other agents used in the study, including known iodide or seafood allergy.
Beschrijving

Allergic Reaction Indocyanine Green | Allergic Reaction Investigational New Drugs | Hypersensitivity Iodide | Allergy to seafood

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0021234
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0021966
UMLS CUI [4]
C0685900
presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the breast and/or axilla, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Beschrijving

Comorbidity Uncontrolled | Breast infection | Infection of axilla | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0392317
UMLS CUI [3]
C1285322
UMLS CUI [4]
C0742758
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0003811
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
UMLS CUI [8,1]
C0748872
UMLS CUI [8,2]
C0439801
UMLS CUI [8,3]
C0525058
pregnant.
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
breastfeeding. patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with icg dye.
Beschrijving

Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Breast Cancer NCT02316795

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Node-negative breast cancer Staging Sentinel Lymph Node Biopsy | Melanoma Staging Sentinel Lymph Node Biopsy
Item
newly diagnosed with clinically node-negative breast cancer or melanoma being staged with sln biopsy.
boolean
C3160889 (UMLS CUI [1,1])
C0332305 (UMLS CUI [1,2])
C0796693 (UMLS CUI [1,3])
C0025202 (UMLS CUI [2,1])
C0332305 (UMLS CUI [2,2])
C0796693 (UMLS CUI [2,3])
Lymphatic Basin Negative Clinical examination
Item
negative nodal basin clinical exam.
boolean
C2986565 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1456356 (UMLS CUI [1,3])
Age
Item
at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
able to understand and willing to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Contraindication to surgery
Item
contraindications for surgery.
boolean
C0852649 (UMLS CUI [1])
Investigational New Drugs
Item
receiving any investigational agents.
boolean
C0013230 (UMLS CUI [1])
Allergic Reaction Indocyanine Green | Allergic Reaction Investigational New Drugs | Hypersensitivity Iodide | Allergy to seafood
Item
history of allergic reactions attributed to icg or other agents used in the study, including known iodide or seafood allergy.
boolean
C1527304 (UMLS CUI [1,1])
C0021234 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0021966 (UMLS CUI [3,2])
C0685900 (UMLS CUI [4])
Comorbidity Uncontrolled | Breast infection | Infection of axilla | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the breast and/or axilla, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0392317 (UMLS CUI [2])
C1285322 (UMLS CUI [3])
C0742758 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0004936 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0439801 (UMLS CUI [8,2])
C0525058 (UMLS CUI [8,3])
Pregnancy
Item
pregnant.
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
breastfeeding. patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with icg dye.
boolean
C0006147 (UMLS CUI [1])
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