ID

39817

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT02003339

Trefwoorden

Versies (2)
  1. 23-02-20 23-02-20 -
  2. 27-09-21 27-09-21 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 februari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02003339

Engels

Eligibility Hepatocellular Carcinoma NCT02003339

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

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

Datatype

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)
Beschrijving

Target Isolated Imaging | Liver carcinoma Invasive Excluded

Datatype

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
Beschrijving

WHO performance status scale

Datatype

boolean

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

Liver Cirrhosis Child-Pugh Classification | Serum total bilirubin measurement

Datatype

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
Beschrijving

Creatinine clearance measurement

Datatype

boolean

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

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

Liver carcinoma Invasive | Absence Tumor Isolated

Datatype

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
Beschrijving

Requirement Therasphere Injection Quantity

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Chemoembolization | Radiofrequency

Datatype

boolean

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

Antiangiogenic therapy

Datatype

boolean

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

Comorbidity Preventing Therapeutic procedure

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

boolean

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

Pregnancy | Childbearing Potential | Breast Feeding

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Informed Consent Unable

Datatype

boolean

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

Eligibility Hepatocellular Carcinoma NCT02003339

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