ID

33395

Beschrijving

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

Trefwoorden

  1. 07-12-18 07-12-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

7 december 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01503697

Eligibility Breast Cancer NCT01503697

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ 18 years.
Beschrijving

Age

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Locally advanced breast cancer | Imaging | Protocol Treatment Arm Number

Datatype

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.
Beschrijving

Informed Consent

Datatype

boolean

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

Pregnancy Absent | Breast Feeding Absent

Datatype

boolean

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

Exclusion Criteria

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

Breast Carcinoma Inconsistent Protocol Treatment Arm

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Breast Cancer NCT01503697

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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