ID

33395

Description

The Role of the Novel 99mTc-NC100692 Tracer in Patients at High Risk or Known Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01503697

Link

https://clinicaltrials.gov/show/NCT01503697

Keywords

  1. 12/7/18 12/7/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 7, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01503697

Eligibility Breast Cancer NCT01503697

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with unknown breast cancer but unclear lesions in the breast on other modalities or patients at high risk for breast cancer (brca, familial)- arm 1
Description

Breast Carcinoma Unknown | Lesion of breast Unclear | At high risk for breast cancer | BRCA Rearrangement | Protocol Treatment Arm Number

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0439673
UMLS CUI [2,1]
C0567489
UMLS CUI [2,2]
C3845108
UMLS CUI [3]
C4047809
UMLS CUI [4]
C4055395
UMLS CUI [5,1]
C1522541
UMLS CUI [5,2]
C0237753
patients with breast cancer referred for 18-fdg pet-ct for staging or re-staging- arm 2
Description

Breast Carcinoma | Referral for FDG PET/CT TNM clinical staging | Referral for FDG PET/CT Restaging | Protocol Treatment Arm Number

Data type

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C2585524
UMLS CUI [2,2]
C4521453
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C2585524
UMLS CUI [3,2]
C4521453
UMLS CUI [3,3]
C4331246
UMLS CUI [4,1]
C1522541
UMLS CUI [4,2]
C0237753
study cohort will include 15 patients with locally advanced breast cancer. patients will undergo imaging prior to treatment and at its end- arm 3
Description

Locally advanced breast cancer | Imaging | Protocol Treatment Arm Number

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0079595
UMLS CUI [3,1]
C1522541
UMLS CUI [3,2]
C0237753
written signed informed consent to participate in the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients not pregnant or lactating.
Description

Pregnancy Absent | Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with breast cancer who do not fall into one of the three study arms.
Description

Breast Carcinoma Inconsistent Protocol Treatment Arm

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C1522541
pregnant or lactating females.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in another investigational study.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Breast Cancer NCT01503697

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Breast Carcinoma Unknown | Lesion of breast Unclear | At high risk for breast cancer | BRCA Rearrangement | Protocol Treatment Arm Number
Item
patients with unknown breast cancer but unclear lesions in the breast on other modalities or patients at high risk for breast cancer (brca, familial)- arm 1
boolean
C0678222 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
C0567489 (UMLS CUI [2,1])
C3845108 (UMLS CUI [2,2])
C4047809 (UMLS CUI [3])
C4055395 (UMLS CUI [4])
C1522541 (UMLS CUI [5,1])
C0237753 (UMLS CUI [5,2])
Breast Carcinoma | Referral for FDG PET/CT TNM clinical staging | Referral for FDG PET/CT Restaging | Protocol Treatment Arm Number
Item
patients with breast cancer referred for 18-fdg pet-ct for staging or re-staging- arm 2
boolean
C0678222 (UMLS CUI [1])
C2585524 (UMLS CUI [2,1])
C4521453 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C2585524 (UMLS CUI [3,1])
C4521453 (UMLS CUI [3,2])
C4331246 (UMLS CUI [3,3])
C1522541 (UMLS CUI [4,1])
C0237753 (UMLS CUI [4,2])
Locally advanced breast cancer | Imaging | Protocol Treatment Arm Number
Item
study cohort will include 15 patients with locally advanced breast cancer. patients will undergo imaging prior to treatment and at its end- arm 3
boolean
C3495949 (UMLS CUI [1])
C0079595 (UMLS CUI [2])
C1522541 (UMLS CUI [3,1])
C0237753 (UMLS CUI [3,2])
Informed Consent
Item
written signed informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent
Item
patients not pregnant or lactating.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma Inconsistent Protocol Treatment Arm
Item
patients with breast cancer who do not fall into one of the three study arms.
boolean
C0678222 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status
Item
participation in another investigational study.
boolean
C2348568 (UMLS CUI [1])

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