ID

39817

Beskrivning

Interest of Functional MRI (Magnetic Resonance Imagery) (in Patients Suffering From Hepatocellular Carcinoma and Treated With Yttrium; ODM derived from: https://clinicaltrials.gov/show/NCT02003339

Länk

https://clinicaltrials.gov/show/NCT02003339

Nyckelord

  1. 2020-02-23 2020-02-23 -
  2. 2021-09-27 2021-09-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 februari 2020

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Hepatocellular Carcinoma NCT02003339

Eligibility Hepatocellular Carcinoma NCT02003339

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
early, intermediate, advanced, non metastatic hepatocellular carcinoma. indication for radioembolization validated after pluridisciplinary committee meeting.
Beskrivning

Early Hepatocellular Carcinoma | Liver carcinoma Intermediate | Liver carcinoma Advanced | Liver carcinoma Without Metastasis | Indication Radioembolisation

Datatyp

boolean

Alias
UMLS CUI [1]
C3273019
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0205103
UMLS CUI [3,1]
C2239176
UMLS CUI [3,2]
C0205179
UMLS CUI [4,1]
C2239176
UMLS CUI [4,2]
C0332288
UMLS CUI [4,3]
C0027627
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C2985560
isolated target on initial imagery (invasive hepatocellular carcinoma excluded)
Beskrivning

Target Isolated Imaging | Liver carcinoma Invasive Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0205409
UMLS CUI [1,3]
C0011923
UMLS CUI [2,1]
C2239176
UMLS CUI [2,2]
C0205281
UMLS CUI [2,3]
C0332196
who (world health organization) performance status: 0, 1 or 2
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
if cirrhosis, child a score with total bilirubin less than 30 micromoles per liter
Beskrivning

Liver Cirrhosis Child-Pugh Classification | Serum total bilirubin measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C2347612
UMLS CUI [2]
C1278039
creatinine clearance more or equal to 30 ml/min
Beskrivning

Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
patient informed and consent signature obtained
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
invasive hepatocellular carcinoma without any isolated tumor
Beskrivning

Liver carcinoma Invasive | Absence Tumor Isolated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205281
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0027651
UMLS CUI [2,3]
C0205409
disease needing 2 injections of therasphere
Beskrivning

Requirement Therasphere Injection Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C1135147
UMLS CUI [1,3]
C1828121
UMLS CUI [1,4]
C1265611
thrombosis extending into the porta(thrombosis of one of left or right branch authorized), extra hepatic metastasis
Beskrivning

Thrombosis Extending Porta hepatis | Thrombosis Left branch of portal vein | Thrombosis Right branch of portal vein | Neoplasm Metastasis Extrahepatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040053
UMLS CUI [1,2]
C0439792
UMLS CUI [1,3]
C0227498
UMLS CUI [2,1]
C0040053
UMLS CUI [2,2]
C0226731
UMLS CUI [3,1]
C0040053
UMLS CUI [3,2]
C0226730
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C1517058
previous treatment by chemoembolization, radiofrequency less than 3 months before radioembolization
Beskrivning

Chemoembolization | Radiofrequency

Datatyp

boolean

Alias
UMLS CUI [1]
C0796679
UMLS CUI [2]
C0579006
no antiangiogenic concomitant treatment, 15 days before and 15 days after radioembolization, including sorafenib
Beskrivning

Antiangiogenic therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C2363719
associated disease which could prevent patient from receiving treatment
Beskrivning

Comorbidity Preventing Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0087111
rmi contre-indication(particle or metal prosthesis, pacemaker, claustrophobia) or contrast product contre-indication (allergy)
Beskrivning

Medical contraindication MRI | Metallic implant | Pacemaker | Claustrophobia | Contrast media allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C3693688
UMLS CUI [3]
C0810633
UMLS CUI [4]
C0008909
UMLS CUI [5]
C0570562
patient already participating in an other therapeutic trial with an experimental drug
Beskrivning

Study Subject Participation Status | Therapy, Investigational | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0949266
UMLS CUI [3]
C0013230
pregnant or childbearing potential women or breastfeeding women
Beskrivning

Pregnancy | Childbearing Potential | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0006147
minors, persons deprived of liberty or protected adults (maintenance of justice, guardianship or supervision) unable to comply with trial medical follow-up for geographical, social or psychological reasons
Beskrivning

Minors | Persons Deprivation Freedom | Guardianship of person | Compliance behavior Unable Clinical Study Follow-up

Datatyp

boolean

Alias
UMLS CUI [1]
C0026193
UMLS CUI [2,1]
C0027361
UMLS CUI [2,2]
C0871712
UMLS CUI [2,3]
C0016694
UMLS CUI [3]
C0680611
UMLS CUI [4,1]
C1321605
UMLS CUI [4,2]
C1299582
UMLS CUI [4,3]
C3274571
unable to sign an informed consent
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582

Similar models

Eligibility Hepatocellular Carcinoma NCT02003339

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Early Hepatocellular Carcinoma | Liver carcinoma Intermediate | Liver carcinoma Advanced | Liver carcinoma Without Metastasis | Indication Radioembolisation
Item
early, intermediate, advanced, non metastatic hepatocellular carcinoma. indication for radioembolization validated after pluridisciplinary committee meeting.
boolean
C3273019 (UMLS CUI [1])
C2239176 (UMLS CUI [2,1])
C0205103 (UMLS CUI [2,2])
C2239176 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C2239176 (UMLS CUI [4,1])
C0332288 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
C3146298 (UMLS CUI [5,1])
C2985560 (UMLS CUI [5,2])
Target Isolated Imaging | Liver carcinoma Invasive Excluded
Item
isolated target on initial imagery (invasive hepatocellular carcinoma excluded)
boolean
C1521840 (UMLS CUI [1,1])
C0205409 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C2239176 (UMLS CUI [2,1])
C0205281 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
WHO performance status scale
Item
who (world health organization) performance status: 0, 1 or 2
boolean
C1298650 (UMLS CUI [1])
Liver Cirrhosis Child-Pugh Classification | Serum total bilirubin measurement
Item
if cirrhosis, child a score with total bilirubin less than 30 micromoles per liter
boolean
C0023890 (UMLS CUI [1,1])
C2347612 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
Creatinine clearance measurement
Item
creatinine clearance more or equal to 30 ml/min
boolean
C0373595 (UMLS CUI [1])
Informed Consent
Item
patient informed and consent signature obtained
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver carcinoma Invasive | Absence Tumor Isolated
Item
invasive hepatocellular carcinoma without any isolated tumor
boolean
C2239176 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0027651 (UMLS CUI [2,2])
C0205409 (UMLS CUI [2,3])
Requirement Therasphere Injection Quantity
Item
disease needing 2 injections of therasphere
boolean
C1514873 (UMLS CUI [1,1])
C1135147 (UMLS CUI [1,2])
C1828121 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Thrombosis Extending Porta hepatis | Thrombosis Left branch of portal vein | Thrombosis Right branch of portal vein | Neoplasm Metastasis Extrahepatic
Item
thrombosis extending into the porta(thrombosis of one of left or right branch authorized), extra hepatic metastasis
boolean
C0040053 (UMLS CUI [1,1])
C0439792 (UMLS CUI [1,2])
C0227498 (UMLS CUI [1,3])
C0040053 (UMLS CUI [2,1])
C0226731 (UMLS CUI [2,2])
C0040053 (UMLS CUI [3,1])
C0226730 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4,1])
C1517058 (UMLS CUI [4,2])
Chemoembolization | Radiofrequency
Item
previous treatment by chemoembolization, radiofrequency less than 3 months before radioembolization
boolean
C0796679 (UMLS CUI [1])
C0579006 (UMLS CUI [2])
Antiangiogenic therapy
Item
no antiangiogenic concomitant treatment, 15 days before and 15 days after radioembolization, including sorafenib
boolean
C2363719 (UMLS CUI [1])
Comorbidity Preventing Therapeutic procedure
Item
associated disease which could prevent patient from receiving treatment
boolean
C0009488 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Medical contraindication MRI | Metallic implant | Pacemaker | Claustrophobia | Contrast media allergy
Item
rmi contre-indication(particle or metal prosthesis, pacemaker, claustrophobia) or contrast product contre-indication (allergy)
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C3693688 (UMLS CUI [2])
C0810633 (UMLS CUI [3])
C0008909 (UMLS CUI [4])
C0570562 (UMLS CUI [5])
Study Subject Participation Status | Therapy, Investigational | Investigational New Drugs
Item
patient already participating in an other therapeutic trial with an experimental drug
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Pregnancy | Childbearing Potential | Breast Feeding
Item
pregnant or childbearing potential women or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Minors | Persons Deprivation Freedom | Guardianship of person | Compliance behavior Unable Clinical Study Follow-up
Item
minors, persons deprived of liberty or protected adults (maintenance of justice, guardianship or supervision) unable to comply with trial medical follow-up for geographical, social or psychological reasons
boolean
C0026193 (UMLS CUI [1])
C0027361 (UMLS CUI [2,1])
C0871712 (UMLS CUI [2,2])
C0016694 (UMLS CUI [2,3])
C0680611 (UMLS CUI [3])
C1321605 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
Informed Consent Unable
Item
unable to sign an informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])

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