ID

43531

Beschrijving

PET Imaging With Cu-64 Labeled Trastuzumab in HER2+ Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00605397

Link

https://clinicaltrials.gov/show/NCT00605397

Trefwoorden

  1. 08-06-17 08-06-17 -
  2. 20-09-21 20-09-21 -
Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00605397

Eligibility Breast Cancer NCT00605397

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
registered patient at mskcc
Beschrijving

ID.1

Datatype

boolean

Alias
UMLS CUI [1]
C1513120
age ≥18 years
Beschrijving

ID.2

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients with her2+ metastatic breast cancer (either 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (fish))
Beschrijving

ID.3

Datatype

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0027627
measurable or evaluable disease
Beschrijving

ID.4

Datatype

boolean

Alias
UMLS CUI [1]
C0449385
currently taking or about to commence treatment with trastuzumab at a dosing schedule of 2 mg/kg weekly or 6 mg/kg every three weeks, as per standard of care
Beschrijving

ID.5

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0728747
karnofsky performance score ≥ 60
Beschrijving

ID.6

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
signed informed consent
Beschrijving

ID.7

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous grade 3 or higher allergic reaction to trastuzumab that resulted in discontinuation of trastuzumab therapy
Beschrijving

ID.8

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0728747
claustrophobia/pain leading to inability to lie still for the duration of the scanning procedure.
Beschrijving

ID.9

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0024485
pregnancy test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material.
Beschrijving

ID.10

Datatype

boolean

Alias
UMLS CUI [1]
C0032976
inability to provide written informed consent.
Beschrijving

ID.11

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients with liver metastases as the only site of distant disease
Beschrijving

ID.12

Datatype

boolean

Alias
UMLS CUI [1]
C0494165
patients with known sensitivity or contraindication to herceptin.
Beschrijving

ID.13

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0338204

Similar models

Eligibility Breast Cancer NCT00605397

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
registered patient at mskcc
boolean
C1513120 (UMLS CUI [1])
ID.2
Item
age ≥18 years
boolean
C0001779 (UMLS CUI [1])
ID.3
Item
patients with her2+ metastatic breast cancer (either 3+ by immunohistochemistry or with evidence of gene amplification (>2.0) by fluorescence in situ hybridization (fish))
boolean
C1960398 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
ID.4
Item
measurable or evaluable disease
boolean
C0449385 (UMLS CUI [1])
ID.5
Item
currently taking or about to commence treatment with trastuzumab at a dosing schedule of 2 mg/kg weekly or 6 mg/kg every three weeks, as per standard of care
boolean
C0013216 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
ID.6
Item
karnofsky performance score ≥ 60
boolean
C0206065 (UMLS CUI [1])
ID.7
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.8
Item
previous grade 3 or higher allergic reaction to trastuzumab that resulted in discontinuation of trastuzumab therapy
boolean
C0020517 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
ID.9
Item
claustrophobia/pain leading to inability to lie still for the duration of the scanning procedure.
boolean
C0008909 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
ID.10
Item
pregnancy test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material.
boolean
C0032976 (UMLS CUI [1])
ID.11
Item
inability to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
ID.12
Item
patients with liver metastases as the only site of distant disease
boolean
C0494165 (UMLS CUI [1])
ID.13
Item
patients with known sensitivity or contraindication to herceptin.
boolean
C0020517 (UMLS CUI [1,1])
C0338204 (UMLS CUI [1,2])

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