ID

39296

Description

F-18 FES PET in Measuring Hormone Expression in Patients With Primary, Recurrent or Metastatic Breast Cancer Undergoing Endocrine-Targeted Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02149173

Link

https://clinicaltrials.gov/show/NCT02149173

Keywords

Versions (1)
  1. 12/17/19 12/17/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 17, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Estrogen Receptor Positive NCT02149173

English

Eligibility Estrogen Receptor Positive NCT02149173

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer
Description

Adult | Pregnancy Absent | Breast cancer recurrent | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0278493
UMLS CUI [4]
C0346993
breast cancer from er+ primary that is seen on other imaging tests; tumor er expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease
Description

Oestrogen receptor positive breast cancer Imaging | Neoplasm Estrogen Receptor Expression | Primary tumor Immunohistochemistry | Recurrent disease Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C2938924
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0034804
UMLS CUI [2,3]
C0017262
UMLS CUI [3,1]
C0677930
UMLS CUI [3,2]
C0021044
UMLS CUI [4,1]
C0277556
UMLS CUI [4,2]
C0021044
at least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of pet imaging
Description

Tumor size Site Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline fes
Description

Tamoxifen Absent | Estrogen Receptor Antagonists Absent | Chemotherapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0039286
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C3850168
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332197
patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist; selected treatments may be part of experimental treatment protocols for which the patient would be separately consented
Description

Endocrine system Targeted Therapy Breast Carcinoma | Therapies, Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0014136
UMLS CUI [1,2]
C2985566
UMLS CUI [1,3]
C0678222
UMLS CUI [2]
C0949266
patients must be willing to undergo serial imaging procedures
Description

Serial imaging

Data type

boolean

Alias
UMLS CUI [1]
C0203640
patients must agree to allow access to clinical records regarding response to treatment and long term follow up
Description

Agreement Access Medical Records

Data type

boolean

Alias
UMLS CUI [1,1]
C0680240
UMLS CUI [1,2]
C0444454
UMLS CUI [1,3]
C0025102
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
an inability to lie still for the tests
Description

Lacking Able to lie down Quiet

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0560841
UMLS CUI [1,3]
C0439654
individuals weighing more than 300 lb; (this is the weight limit of the scanner table)
Description

Body Weight Inappropriate Scanner Device

Data type

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1710020
pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded
Description

Pregnancy | Breast Feeding | Pregnancy test positive | Pregnancy Test Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0240802
UMLS CUI [4,1]
C0032976
UMLS CUI [4,2]
C0332268
any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication)
Description

Life threatening illness | Communicable Disease Serious Uncontrolled | Heart Disease | Congestive heart failure | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia Poorly controlled

Data type

boolean

Alias
UMLS CUI [1]
C3846017
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0205318
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0018802
UMLS CUI [5,1]
C1956346
UMLS CUI [5,2]
C0231220
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C3853134
use of tamoxifen, faslodex, diethylstilbestrol (des) or any other er blocking agent < 6 weeks or chemotherapy < 3 weeks prior to imaging scan
Description

Tamoxifen | Faslodex | Diethylstilbestrol | Estrogen Receptor Antagonists Recent | Chemotherapy Recent

Data type

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0701491
UMLS CUI [3]
C0012203
UMLS CUI [4,1]
C3850168
UMLS CUI [4,2]
C0332185
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C0332185
unwillingness or inability to give informed consent
Description

Informed Consent Unwilling | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
uncontrolled diabetes mellitus (fasting glucose > 200 mg/dl)
Description

Diabetic - poor control | Glucose measurement, fasting

Data type

boolean

Alias
UMLS CUI [1]
C0421258
UMLS CUI [2]
C0202045
adult patients who require monitored anesthesia for pet scanning
Description

Adult | Requirement Monitored anesthesia care PET scan

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0497677
UMLS CUI [2,3]
C0032743
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Similar models

Eligibility Estrogen Receptor Positive NCT02149173

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Pregnancy Absent | Breast cancer recurrent | Secondary malignant neoplasm of female breast
Item
adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer
boolean
C0001675 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0278493 (UMLS CUI [3])
C0346993 (UMLS CUI [4])
Oestrogen receptor positive breast cancer Imaging | Neoplasm Estrogen Receptor Expression | Primary tumor Immunohistochemistry | Recurrent disease Immunohistochemistry
Item
breast cancer from er+ primary that is seen on other imaging tests; tumor er expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease
boolean
C2938924 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0034804 (UMLS CUI [2,2])
C0017262 (UMLS CUI [2,3])
C0677930 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4,1])
C0021044 (UMLS CUI [4,2])
Tumor size Site Quantity
Item
at least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of pet imaging
boolean
C0475440 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Tamoxifen Absent | Estrogen Receptor Antagonists Absent | Chemotherapy Absent
Item
patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline fes
boolean
C0039286 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3850168 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Endocrine system Targeted Therapy Breast Carcinoma | Therapies, Investigational
Item
patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist; selected treatments may be part of experimental treatment protocols for which the patient would be separately consented
boolean
C0014136 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
C0949266 (UMLS CUI [2])
Serial imaging
Item
patients must be willing to undergo serial imaging procedures
boolean
C0203640 (UMLS CUI [1])
Agreement Access Medical Records
Item
patients must agree to allow access to clinical records regarding response to treatment and long term follow up
boolean
C0680240 (UMLS CUI [1,1])
C0444454 (UMLS CUI [1,2])
C0025102 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Lacking Able to lie down Quiet
Item
an inability to lie still for the tests
boolean
C0332268 (UMLS CUI [1,1])
C0560841 (UMLS CUI [1,2])
C0439654 (UMLS CUI [1,3])
Body Weight Inappropriate Scanner Device
Item
individuals weighing more than 300 lb; (this is the weight limit of the scanner table)
boolean
C0005910 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1710020 (UMLS CUI [1,3])
Pregnancy | Breast Feeding | Pregnancy test positive | Pregnancy Test Lacking
Item
pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0240802 (UMLS CUI [3])
C0032976 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Life threatening illness | Communicable Disease Serious Uncontrolled | Heart Disease | Congestive heart failure | Coronary Artery Disease Symptomatic | Cardiac Arrhythmia Poorly controlled
Item
any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication)
boolean
C3846017 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0205318 (UMLS CUI [2,3])
C0018799 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C1956346 (UMLS CUI [5,1])
C0231220 (UMLS CUI [5,2])
C0003811 (UMLS CUI [6,1])
C3853134 (UMLS CUI [6,2])
Tamoxifen | Faslodex | Diethylstilbestrol | Estrogen Receptor Antagonists Recent | Chemotherapy Recent
Item
use of tamoxifen, faslodex, diethylstilbestrol (des) or any other er blocking agent < 6 weeks or chemotherapy < 3 weeks prior to imaging scan
boolean
C0039286 (UMLS CUI [1])
C0701491 (UMLS CUI [2])
C0012203 (UMLS CUI [3])
C3850168 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C0392920 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
Informed Consent Unwilling | Informed Consent Unable
Item
unwillingness or inability to give informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Diabetic - poor control | Glucose measurement, fasting
Item
uncontrolled diabetes mellitus (fasting glucose > 200 mg/dl)
boolean
C0421258 (UMLS CUI [1])
C0202045 (UMLS CUI [2])
Adult | Requirement Monitored anesthesia care PET scan
Item
adult patients who require monitored anesthesia for pet scanning
boolean
C0001675 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0497677 (UMLS CUI [2,2])
C0032743 (UMLS CUI [2,3])
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