ID

27296

Beschrijving

A Study to Determine the Value of 18F-FAZA PET Imaging in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00771381

Link

https://clinicaltrials.gov/show/NCT00771381

Trefwoorden

Versies (1)
  1. 07-11-17 07-11-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

7 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Neoplasm NCT00771381

Engels

Eligibility Breast Neoplasm NCT00771381

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female ≥ 18 years of age. if female of child bearing potential and if outside of the window of 10 days since the first day of the 0last menstrual period, patient will be required to have a negative pregnancy test.
Beschrijving

Gender | Age | Childbearing Potential Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
2. pathologically proven invasive duct carcinoma of the breast (fna or core biopsy), t1-t4(t ≥ 1.5 cm)
Beschrijving

Invasive Ductal Breast Carcinoma TNM Breast tumor staging Fine needle aspiration | Invasive Ductal Breast Carcinoma TNM Breast tumor staging Core needle biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1134719
UMLS CUI [1,2]
C0474926
UMLS CUI [1,3]
C1510483
UMLS CUI [2,1]
C1134719
UMLS CUI [2,2]
C0474926
UMLS CUI [2,3]
C1318309
3. fluglucoscan injection and 18f-faza pet scans performed prior to treatment.
Beschrijving

Fluorodeoxyglucose F18 Injection | 18F-FAZA PET scan

Datatype

boolean

Alias
UMLS CUI [1,1]
C0046056
UMLS CUI [1,2]
C1533685
UMLS CUI [2,1]
C1566975
UMLS CUI [2,2]
C0032743
4. fluglucoscan injection and 18f-faza pet scans performed within 4 weeks prior to their definitive surgery if subject does not have neoadjuvant therapy.
Beschrijving

Fluorodeoxyglucose F18 Injection | 18F-FAZA PET scan | Operative Surgical Procedures Definitive | Neoadjuvant Therapy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0046056
UMLS CUI [1,2]
C1533685
UMLS CUI [2,1]
C1566975
UMLS CUI [2,2]
C0032743
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0443196
UMLS CUI [4,1]
C0600558
UMLS CUI [4,2]
C0332197
5. able and willing to follow instructions and comply with the protocol
Beschrijving

Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
6. provide written informed consent prior to participation in the study.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
7. ecog performance score ≤ 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous malignancy or diagnosis less than ten (10) years ago. skin cancers (excluding malignant melanoma) and carcinoma in situ of the cervix are exceptions.
Beschrijving

Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Melanoma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4]
C0025202
2. excisional biopsy of the primary breast tumour has been performed
Beschrijving

Excision biopsy Breast Carcinoma Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0184921
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0205225
3. women with an invasive carcinoma of the breast that is not predominantly of the invasive duct subtype
Beschrijving

Gender | Invasive carcinoma of breast | Exception Invasive Ductal Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0853879
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1134719
4. primary breast carcinoma previously treated.
Beschrijving

Prior Therapy Breast Carcinoma Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0205225
5. women who are nursing or pregnant.
Beschrijving

Breast Feeding | Pregnancy

Datatype

boolean

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

Eligibility Breast Neoplasm NCT00771381

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Childbearing Potential Pregnancy test negative
Item
1. female ≥ 18 years of age. if female of child bearing potential and if outside of the window of 10 days since the first day of the 0last menstrual period, patient will be required to have a negative pregnancy test.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
Invasive Ductal Breast Carcinoma TNM Breast tumor staging Fine needle aspiration | Invasive Ductal Breast Carcinoma TNM Breast tumor staging Core needle biopsy
Item
2. pathologically proven invasive duct carcinoma of the breast (fna or core biopsy), t1-t4(t ≥ 1.5 cm)
boolean
C1134719 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C1510483 (UMLS CUI [1,3])
C1134719 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
C1318309 (UMLS CUI [2,3])
Fluorodeoxyglucose F18 Injection | 18F-FAZA PET scan
Item
3. fluglucoscan injection and 18f-faza pet scans performed prior to treatment.
boolean
C0046056 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C1566975 (UMLS CUI [2,1])
C0032743 (UMLS CUI [2,2])
Fluorodeoxyglucose F18 Injection | 18F-FAZA PET scan | Operative Surgical Procedures Definitive | Neoadjuvant Therapy Absent
Item
4. fluglucoscan injection and 18f-faza pet scans performed within 4 weeks prior to their definitive surgery if subject does not have neoadjuvant therapy.
boolean
C0046056 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C1566975 (UMLS CUI [2,1])
C0032743 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C0443196 (UMLS CUI [3,2])
C0600558 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Protocol Compliance
Item
5. able and willing to follow instructions and comply with the protocol
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
6. provide written informed consent prior to participation in the study.
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
7. ecog performance score ≤ 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Melanoma
Item
1. previous malignancy or diagnosis less than ten (10) years ago. skin cancers (excluding malignant melanoma) and carcinoma in situ of the cervix are exceptions.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C0025202 (UMLS CUI [4])
Excision biopsy Breast Carcinoma Primary
Item
2. excisional biopsy of the primary breast tumour has been performed
boolean
C0184921 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Gender | Invasive carcinoma of breast | Exception Invasive Ductal Breast Carcinoma
Item
3. women with an invasive carcinoma of the breast that is not predominantly of the invasive duct subtype
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1134719 (UMLS CUI [3,2])
Prior Therapy Breast Carcinoma Primary
Item
4. primary breast carcinoma previously treated.
boolean
C1514463 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Breast Feeding | Pregnancy
Item
5. women who are nursing or pregnant.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
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