ID

43680

Description

FBnTP Imaging of Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02204462

Link

https://clinicaltrials.gov/show/NCT02204462

Keywords

Versions (2)
  1. 4/26/16 4/26/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02204462

English

Eligibility Breast Cancer NCT02204462

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e., index cancer)
Description

Female | Invasive breast carcinoma | Intraductal breast cancer (in situ) | Core needle biopsy of breast | Vacuum-Assisted Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0086287
UMLS CUI [2]
C0853879
UMLS CUI [3]
C0861351
UMLS CUI [4]
C0191853
UMLS CUI [5]
C1710607
age > 25 ability and willingness to sign informed consent prior to any study procedure.
Description

Age | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
positive indication of disease on mammogram or mri scan.
Description

Indication Disease | Mammography | MRI Scan

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C0024671
UMLS CUI [3]
C0917711
candidate for breast cancer surgery on the basis of recommendation of a breast cancer surgeon.
Description

Appropriate Operative Surgical Procedures Malignant neoplasm of breast

Data type

boolean

Alias
UMLS CUI [1,1]
C1548787
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0006142
ability to undergo up to 90 minutes of pem imaging.
Description

Ability Positron Emission Mammography

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C3897879
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any active or chronic illness that, in the opinion of the investigators, would make the study unsafe or limit compliance with study procedures.
Description

Disease Affecting Clinical Research | Disease Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0008972
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C0439801
past or present history of active substance abuse (drug or alcohol).
Description

Substance abuse problem

Data type

boolean

Alias
UMLS CUI [1]
C0740858
inability to tolerate venous access.
Description

Unable venous access

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0750164
pregnant females are excluded from this study. all females of child-bearing potential will undergo a serum pregnancy test within 48 hours prior to fbntp administration.
Description

Pregnancy | Female Childbearing Potential Serum pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0086287
UMLS CUI [2,2]
C3831118
UMLS CUI [2,3]
C0430064
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Similar models

Eligibility Breast Cancer NCT02204462

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Female | Invasive breast carcinoma | Intraductal breast cancer (in situ) | Core needle biopsy of breast | Vacuum-Assisted Biopsy
Item
female patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e., index cancer)
boolean
C0086287 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
C0861351 (UMLS CUI [3])
C0191853 (UMLS CUI [4])
C1710607 (UMLS CUI [5])
Age | Informed Consent
Item
age > 25 ability and willingness to sign informed consent prior to any study procedure.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Indication Disease | Mammography | MRI Scan
Item
positive indication of disease on mammogram or mri scan.
boolean
C3146298 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0024671 (UMLS CUI [2])
C0917711 (UMLS CUI [3])
Appropriate Operative Surgical Procedures Malignant neoplasm of breast
Item
candidate for breast cancer surgery on the basis of recommendation of a breast cancer surgeon.
boolean
C1548787 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0006142 (UMLS CUI [1,3])
Ability Positron Emission Mammography
Item
ability to undergo up to 90 minutes of pem imaging.
boolean
C0085732 (UMLS CUI [1,1])
C3897879 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Disease Affecting Clinical Research | Disease Compliance behavior Limited
Item
any active or chronic illness that, in the opinion of the investigators, would make the study unsafe or limit compliance with study procedures.
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Substance abuse problem
Item
past or present history of active substance abuse (drug or alcohol).
boolean
C0740858 (UMLS CUI [1])
Unable venous access
Item
inability to tolerate venous access.
boolean
C1299582 (UMLS CUI [1,1])
C0750164 (UMLS CUI [1,2])
Pregnancy | Female Childbearing Potential Serum pregnancy test
Item
pregnant females are excluded from this study. all females of child-bearing potential will undergo a serum pregnancy test within 48 hours prior to fbntp administration.
boolean
C0032961 (UMLS CUI [1])
C0086287 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0430064 (UMLS CUI [2,3])
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