ID

26983

Description

Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00981812

Link

https://clinicaltrials.gov/show/NCT00981812

Keywords

Versions (1)
  1. 10/29/17 10/29/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 29, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00981812

English

Eligibility Breast Cancer NCT00981812

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
subject is 25-100 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy
Description

Female Mammography Quantity Suggestive of Malignant Neoplasm | Mammary Ultrasonography Quantity Suggestive of Malignant Neoplasm | Recommendation Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0848600
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0332299
UMLS CUI [1,4]
C0006826
UMLS CUI [2,1]
C0080264
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0332299
UMLS CUI [2,4]
C0006826
UMLS CUI [3,1]
C0034866
UMLS CUI [3,2]
C0005558
subject is able to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject is pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
subject is actively lactating or discontinued breastfeeding less than 2 months ago
Description

Breast Feeding | Breast Feeding Discontinued Recently

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0332185
subject has breast implants
Description

Breast implants

Data type

boolean

Alias
UMLS CUI [1]
C0179412
subject is scheduled for sentinel node procedure using radioactive tc-99m within 24 hours of the pem study
Description

Sentinel Lymph Node Biopsy Technetium 99m Scheduled | Positron Emission Mammography

Data type

boolean

Alias
UMLS CUI [1,1]
C0796693
UMLS CUI [1,2]
C0303611
UMLS CUI [1,3]
C0205539
UMLS CUI [2]
C3897879
subject has contraindications for core biopsy and other invasive procedures
Description

Medical contraindication Core needle biopsy | Medical contraindication Invasive procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1318309
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C4048276
subject has type i diabetes mellitus or poorly controlled type ii diabetes mellitus
Description

Diabetes Mellitus, Insulin-Dependent | Type II diabetes mellitus uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C2733146
subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months
Description

Therapeutic radiology procedure Breast Involved | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0006141
UMLS CUI [1,3]
C1314939
UMLS CUI [2]
C0392920
subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of pem imaging
Description

Fasting Lacking | Fasting blood glucose measurement | Positron Emission Mammography

Data type

boolean

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C0332268
UMLS CUI [2]
C0428568
UMLS CUI [3]
C3897879
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Similar models

Eligibility Breast Cancer NCT00981812

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Age
Item
subject is 25-100 years of age
boolean
C0001779 (UMLS CUI [1])
Female Mammography Quantity Suggestive of Malignant Neoplasm | Mammary Ultrasonography Quantity Suggestive of Malignant Neoplasm | Recommendation Biopsy
Item
subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy
boolean
C0848600 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332299 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C0080264 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332299 (UMLS CUI [2,3])
C0006826 (UMLS CUI [2,4])
C0034866 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
Informed Consent
Item
subject is able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
subject is pregnant
boolean
C0032961 (UMLS CUI [1])
Breast Feeding | Breast Feeding Discontinued Recently
Item
subject is actively lactating or discontinued breastfeeding less than 2 months ago
boolean
C0006147 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Breast implants
Item
subject has breast implants
boolean
C0179412 (UMLS CUI [1])
Sentinel Lymph Node Biopsy Technetium 99m Scheduled | Positron Emission Mammography
Item
subject is scheduled for sentinel node procedure using radioactive tc-99m within 24 hours of the pem study
boolean
C0796693 (UMLS CUI [1,1])
C0303611 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C3897879 (UMLS CUI [2])
Medical contraindication Core needle biopsy | Medical contraindication Invasive procedure
Item
subject has contraindications for core biopsy and other invasive procedures
boolean
C1301624 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C4048276 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent | Type II diabetes mellitus uncontrolled
Item
subject has type i diabetes mellitus or poorly controlled type ii diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
C2733146 (UMLS CUI [2])
Therapeutic radiology procedure Breast Involved | Chemotherapy
Item
subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months
boolean
C1522449 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2])
Fasting Lacking | Fasting blood glucose measurement | Positron Emission Mammography
Item
subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of pem imaging
boolean
C0015663 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0428568 (UMLS CUI [2])
C3897879 (UMLS CUI [3])
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