ID

40923

Description

24hr Imaging Of HCC After EOVIST; ODM derived from: https://clinicaltrials.gov/show/NCT01968629

Link

https://clinicaltrials.gov/show/NCT01968629

Keywords

Versions (1)
  1. 6/6/20 6/6/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 6, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01968629

English

Eligibility Hepatocellular Carcinoma NCT01968629

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants must meet the following criteria on screening examination to be eligible to participate in the study:
Description

Inclusion criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
participants must have histologically or cytologically confirmed hepatocellular carcinoma or have an imaging study that demonstrates a focal hepatic lesion with imaging features diagnostic of hepatocellular carcinoma.
Description

Liver carcinoma | Lesion of liver Focal Imaging study | Imaging Feature Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2,1]
C0577053
UMLS CUI [2,2]
C0205234
UMLS CUI [2,3]
C1881134
UMLS CUI [3,1]
C2346469
UMLS CUI [3,2]
C2239176
participants must be scheduled to undergo an eovist-enhanced mri of the liver as a part of their standard of care.
Description

Eovist MRI Liver Scheduled | Standard of Care

Data type

boolean

Alias
UMLS CUI [1,1]
C0675788
UMLS CUI [1,2]
C0024485
UMLS CUI [1,3]
C0023884
UMLS CUI [1,4]
C0205539
UMLS CUI [2]
C2936643
participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with mri.
Description

Measurable Disease | Measurable lesion Quantity | Measurable lesion Dimensions Quantity | Lesion Longest Diameter

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C0439534
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C0552406
because no dosing or adverse event data are currently available on the use of eovist in participants <18 years of age, and because hcc is exceedingly rare in the pediatric population, children are excluded from this study.
Description

Age | Children Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0008059
UMLS CUI [2,2]
C0332196
the effects of eovist on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0036899
ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
Description

Patient condition Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0683521
UMLS CUI [1,2]
C1512714
participants who have had chemotherapy, radiofrequency ablation, microwave ablation, chemo-embolization, or radiotherapy within 4 weeks prior to entering the study.
Description

Chemotherapy | Radiofrequency ablation | Microwave ablation | Chemoembolization | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0850292
UMLS CUI [3]
C3854551
UMLS CUI [4]
C0796679
UMLS CUI [5]
C1522449
history of allergic reactions attributed to compounds of similar chemical or biologic composition to eovist.
Description

Allergic Reaction Compound Eovist Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0675788
UMLS CUI [1,4]
C2348205
patients with glomerular filtration rates < 30 ml/min/1.73m2.
Description

Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0017654
patients who are unable to undergo mri imaging.
Description

MRI Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
patients who are pregnant.
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Hepatocellular Carcinoma NCT01968629

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Fulfill
Item
participants must meet the following criteria on screening examination to be eligible to participate in the study:
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Liver carcinoma | Lesion of liver Focal Imaging study | Imaging Feature Liver carcinoma
Item
participants must have histologically or cytologically confirmed hepatocellular carcinoma or have an imaging study that demonstrates a focal hepatic lesion with imaging features diagnostic of hepatocellular carcinoma.
boolean
C2239176 (UMLS CUI [1])
C0577053 (UMLS CUI [2,1])
C0205234 (UMLS CUI [2,2])
C1881134 (UMLS CUI [2,3])
C2346469 (UMLS CUI [3,1])
C2239176 (UMLS CUI [3,2])
Eovist MRI Liver Scheduled | Standard of Care
Item
participants must be scheduled to undergo an eovist-enhanced mri of the liver as a part of their standard of care.
boolean
C0675788 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0023884 (UMLS CUI [1,3])
C0205539 (UMLS CUI [1,4])
C2936643 (UMLS CUI [2])
Measurable Disease | Measurable lesion Quantity | Measurable lesion Dimensions Quantity | Lesion Longest Diameter
Item
participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with mri.
boolean
C1513041 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3,1])
C0439534 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0221198 (UMLS CUI [4,1])
C0552406 (UMLS CUI [4,2])
Age | Children Excluded
Item
because no dosing or adverse event data are currently available on the use of eovist in participants <18 years of age, and because hcc is exceedingly rare in the pediatric population, children are excluded from this study.
boolean
C0001779 (UMLS CUI [1])
C0008059 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
the effects of eovist on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patient condition Ineligible
Item
participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
boolean
C0683521 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
Chemotherapy | Radiofrequency ablation | Microwave ablation | Chemoembolization | Therapeutic radiology procedure
Item
participants who have had chemotherapy, radiofrequency ablation, microwave ablation, chemo-embolization, or radiotherapy within 4 weeks prior to entering the study.
boolean
C0392920 (UMLS CUI [1])
C0850292 (UMLS CUI [2])
C3854551 (UMLS CUI [3])
C0796679 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Allergic Reaction Compound Eovist Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to eovist.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0675788 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Glomerular Filtration Rate
Item
patients with glomerular filtration rates < 30 ml/min/1.73m2.
boolean
C0017654 (UMLS CUI [1])
MRI Receive Unable
Item
patients who are unable to undergo mri imaging.
boolean
C0024485 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Pregnancy
Item
patients who are pregnant.
boolean
C0032961 (UMLS CUI [1])
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