ID

36446

Beschrijving

Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver; ODM derived from: https://clinicaltrials.gov/show/NCT01501240 Brief Summary: A prospective intra-individual study to investigate the diagnostic performance of gadoxetic acid-enhanced MR for the patients with liver cirrhosis using thin-section whole-explant as standard of reference

Link

https://clinicaltrials.gov/show/NCT01501240

Trefwoorden

Versies (2)
  1. 17-01-19 17-01-19 -
  2. 14-05-19 14-05-19 -
Houder van rechten

Jae Ho Byun

Geüploaded op

14 mei 2019

DOI

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Licentie

Creative Commons BY-NC 3.0
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MR Evaluation of Hepatocellular Carcinoma NCT01501240

Engels

Eligibility Criteria

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is there liver cirrhosis ? (based on either histology, or a combination of physical examination, laboratory tests, and imaging data)
Beschrijving

Confirmed liver cirrhosis?

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0019638
UMLS CUI [2,1]
C0023890
UMLS CUI [2,2]
C0205195
UMLS CUI [2,3]
C0031809
UMLS CUI [2,4]
C0022885
UMLS CUI [2,5]
C0025086
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
Is the patient under 20 years of age?
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Does the patient have more than 10 nodules detected on hepatobiliary phase of gadoxetic acid-enhanced mr?
Beschrijving

Patients under 20 years of age (are to be excluded)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0745761
UMLS CUI [1,2]
C0449788
UMLS CUI [1,3]
C3496055
UMLS CUI [1,4]
C3489483
UMLS CUI [1,5]
C0024485
Did the patient undergo transarterial chemotherapy or radiofrequency ablation?
Beschrijving

Assess if the patient was treated with chemo or radiotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0522522
UMLS CUI [1,2]
C3665472
UMLS CUI [2]
C0850292
Is the women pregnant, lactating or of childbearing potential?
Beschrijving

women who are pregnant, lactating or who are of childbearing potential (are to be excluded)

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3]
C0022925
Is the patients physical or mental status interfering with the signing of informed consent?
Beschrijving

patients with any physical or mental status that interferes with the signing of informed consent (are to be excluded)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0597240
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1519316
UMLS CUI [1,4]
C0021430
UMLS CUI [2,1]
C0278060
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1519316
UMLS CUI [2,4]
C0021430
Are there contraindications for MR?
Beschrijving

patients with a contraindication for mr (are to be excluded)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1301624
Does the patient have impaired renal function (e.g. acute renal failure or egfr < 30 ml/min/1.73m2) or is on dialysis?
Beschrijving

patients with impaired renal function (e.g. acute renal failure or egfr < 30 ml/min/1.73m2) or patients on dialysis (are to be excluded)

Datatype

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C0011946
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Similar models

Eligibility Criteria

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Disease Status
Item
Is there liver cirrhosis ? (based on either histology, or a combination of physical examination, laboratory tests, and imaging data)
boolean
C0023890 (UMLS CUI [1,1])
C0019638 (UMLS CUI [1,2])
C0023890 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
C0022885 (UMLS CUI [2,4])
C0025086 (UMLS CUI [2,5])
Item Group
C0680251 (UMLS CUI)
Age
Item
Is the patient under 20 years of age?
boolean
C0001779 (UMLS CUI [1])
Nodules in MR
Item
Does the patient have more than 10 nodules detected on hepatobiliary phase of gadoxetic acid-enhanced mr?
boolean
C0745761 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C3496055 (UMLS CUI [1,3])
C3489483 (UMLS CUI [1,4])
C0024485 (UMLS CUI [1,5])
Non-surgical cancer treatment
Item
Did the patient undergo transarterial chemotherapy or radiofrequency ablation?
boolean
C0522522 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C0850292 (UMLS CUI [2])
Pregancy, Lactation & Childbearing Potential
Item
Is the women pregnant, lactating or of childbearing potential?
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0022925 (UMLS CUI [3])
Capacity to conset
Item
Is the patients physical or mental status interfering with the signing of informed consent?
boolean
C0597240 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
C0278060 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1519316 (UMLS CUI [2,3])
C0021430 (UMLS CUI [2,4])
MRI Contraindications
Item
Are there contraindications for MR?
boolean
C0024485 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
Renal function
Item
Does the patient have impaired renal function (e.g. acute renal failure or egfr < 30 ml/min/1.73m2) or is on dialysis?
boolean
C0232804 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0011946 (UMLS CUI [2])
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