ID

37731

Beskrivning

Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis; ODM derived from: https://clinicaltrials.gov/show/NCT01956409

Länk

https://clinicaltrials.gov/show/NCT01956409

Nyckelord

Versioner (1)
  1. 2019-08-20 2019-08-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer Diagnosis NCT01956409

Engelsk

Eligibility Breast Cancer Diagnosis NCT01956409

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
women aged 20-75 years old.
Beskrivning

Gender | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
with localized findings on mammography or breast ultrasound in recent 3 months and who will receive breast biopsy or excision for the findings; or with recently diagnosed labc who will receive nac.
Beskrivning

Finding Localized Mammography | Finding Localized Breast ultrasound | Biopsy of breast Planned | Breast excision Planned | Locally advanced breast cancer | Neoadjuvant Chemotherapy Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0392752
UMLS CUI [1,3]
C0024671
UMLS CUI [2,1]
C0243095
UMLS CUI [2,2]
C0392752
UMLS CUI [2,3]
C0080264
UMLS CUI [3,1]
C0405352
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0191848
UMLS CUI [4,2]
C1301732
UMLS CUI [5]
C3495949
UMLS CUI [6,1]
C0600558
UMLS CUI [6,2]
C3665472
UMLS CUI [6,3]
C1301732
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable to cooperate with the examinations
Beskrivning

Compliance Medical Examinations Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0582103
UMLS CUI [1,3]
C1299582
pregnant or planning to be pregnant
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
estimated gfr (egfr) < 60 ml/min/1.73m2 or with recent acute renal failure, past history of renal dialysis.
Beskrivning

Estimated Glomerular Filtration Rate | Kidney Failure | Dialysis

Datatyp

boolean

Alias
UMLS CUI [1]
C3811844
UMLS CUI [2]
C0035078
UMLS CUI [3]
C0011946
past history of claustrophobia
Beskrivning

Claustrophobia

Datatyp

boolean

Alias
UMLS CUI [1]
C0008909
past history of anaphylactoid reactions to mri contrast agents or pet tracer agents.
Beskrivning

Anaphylactoid reaction MRI contrast media | Anaphylactoid reaction PET Tracer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0340865
UMLS CUI [1,2]
C0180108
UMLS CUI [2,1]
C0340865
UMLS CUI [2,2]
C0032743
UMLS CUI [2,3]
C1522485
with cardiac pacemaker, aneurysmal clip, mechanical valve replacement, recently applied coronary artery stent (<2 months).
Beskrivning

Artificial cardiac pacemaker | Aneurysm clip | Mechanical heart valve replacement | Placement of stent in coronary artery

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0179977
UMLS CUI [3]
C3697840
UMLS CUI [4]
C0521232
past history of breast cancer or other malignancy (treated within 5 years).
Beskrivning

Breast Carcinoma In the past Treated | Cancer Other In the past Treated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1444637
UMLS CUI [1,3]
C1522326
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C1444637
UMLS CUI [2,3]
C1522326
lactating.
Beskrivning

Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
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Similar models

Eligibility Breast Cancer Diagnosis NCT01956409

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women aged 20-75 years old.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Finding Localized Mammography | Finding Localized Breast ultrasound | Biopsy of breast Planned | Breast excision Planned | Locally advanced breast cancer | Neoadjuvant Chemotherapy Planned
Item
with localized findings on mammography or breast ultrasound in recent 3 months and who will receive breast biopsy or excision for the findings; or with recently diagnosed labc who will receive nac.
boolean
C0243095 (UMLS CUI [1,1])
C0392752 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,3])
C0243095 (UMLS CUI [2,1])
C0392752 (UMLS CUI [2,2])
C0080264 (UMLS CUI [2,3])
C0405352 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0191848 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C3495949 (UMLS CUI [5])
C0600558 (UMLS CUI [6,1])
C3665472 (UMLS CUI [6,2])
C1301732 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Compliance Medical Examinations Unable
Item
unable to cooperate with the examinations
boolean
C1321605 (UMLS CUI [1,1])
C0582103 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Pregnancy | Pregnancy, Planned
Item
pregnant or planning to be pregnant
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Estimated Glomerular Filtration Rate | Kidney Failure | Dialysis
Item
estimated gfr (egfr) < 60 ml/min/1.73m2 or with recent acute renal failure, past history of renal dialysis.
boolean
C3811844 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Claustrophobia
Item
past history of claustrophobia
boolean
C0008909 (UMLS CUI [1])
Anaphylactoid reaction MRI contrast media | Anaphylactoid reaction PET Tracer
Item
past history of anaphylactoid reactions to mri contrast agents or pet tracer agents.
boolean
C0340865 (UMLS CUI [1,1])
C0180108 (UMLS CUI [1,2])
C0340865 (UMLS CUI [2,1])
C0032743 (UMLS CUI [2,2])
C1522485 (UMLS CUI [2,3])
Artificial cardiac pacemaker | Aneurysm clip | Mechanical heart valve replacement | Placement of stent in coronary artery
Item
with cardiac pacemaker, aneurysmal clip, mechanical valve replacement, recently applied coronary artery stent (<2 months).
boolean
C0030163 (UMLS CUI [1])
C0179977 (UMLS CUI [2])
C3697840 (UMLS CUI [3])
C0521232 (UMLS CUI [4])
Breast Carcinoma In the past Treated | Cancer Other In the past Treated
Item
past history of breast cancer or other malignancy (treated within 5 years).
boolean
C0678222 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C1522326 (UMLS CUI [1,3])
C1707251 (UMLS CUI [2,1])
C1444637 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
Breast Feeding
Item
lactating.
boolean
C0006147 (UMLS CUI [1])
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