ID

41014

Description

Dynamic Contrast-enhanced Magnetic Resonance Imaging in Evaluation of Liver Functional Status and Treatment Efficacy in Patients With Hepatocellular Carcinoma After Locoregional Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01281683

Link

https://clinicaltrials.gov/show/NCT01281683

Keywords

Versions (2)
  1. 6/12/20 6/12/20 -
  2. 9/17/21 9/17/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 12, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT01281683

English

Eligibility Hepatocellular Carcinoma NCT01281683

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
6.1.1. hcc diagnosed according to the aasld guideline1: tumor size > 1cm in a cirrhotic liver with typical appearance in one dynamic imaging study (hypervascular in the arterial phase with washout in the portal venous or delayed phase), or the tumor is biopsied.
Description

Liver carcinoma | Tumor size | Liver Cirrhosis Imaging study | Hypervascular Phase Arterial | Washout Phase Portal vein | Washout Phase Delayed | Tumor Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0475440
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C1881134
UMLS CUI [4,1]
C1512560
UMLS CUI [4,2]
C0205390
UMLS CUI [4,3]
C0221464
UMLS CUI [5,1]
C1710661
UMLS CUI [5,2]
C0205390
UMLS CUI [5,3]
C0032718
UMLS CUI [6,1]
C1710661
UMLS CUI [6,2]
C0205390
UMLS CUI [6,3]
C0205421
UMLS CUI [7,1]
C0027651
UMLS CUI [7,2]
C0005558
6.1.2. patients who had undergone surgery for the treatment of hcc are allowed. 6.1.3. at least one measurable tumor, according to recist version 1.1. 6.1.4. age 18 years. 6.1.5. chronic hepatitis b. 6.1.6. ecog performance status 0 or 1. 6.1.7. life expectancy 2 months. 6.1.8. child-pugh class a or b liver function with a child-pugh score of ≦ 8. 6.1.9. liver transaminases (alt and ast) 300 iu/l; total bilirubin 2 mg/dl; serum creatinine 2 mg/dl.
Description

Operative Surgical Procedure Liver carcinoma | Measurable lesion Quantity | Age | Hepatitis B, Chronic | ECOG performance status | Life Expectancy | Child-Pugh Classification | Liver function Child-Pugh - Total Score | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C2239176
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0524909
UMLS CUI [5]
C1520224
UMLS CUI [6]
C0023671
UMLS CUI [7]
C2347612
UMLS CUI [8,1]
C0232741
UMLS CUI [8,2]
C4055253
UMLS CUI [9]
C0201836
UMLS CUI [10]
C0201899
UMLS CUI [11]
C1278039
UMLS CUI [12]
C0201976
6.1.10.specific criteria for the tace cohort: tumors distributed within one lobe and with maximal diameter of 10cm (for adequate amount of non-tumorous liver parenchyma for evaluation).
Description

Criteria TACE Cohort | Neoplasms Lobe Single | Neoplasm Diameter Maximal

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C3539919
UMLS CUI [1,3]
C0599755
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0796494
UMLS CUI [2,3]
C0205171
UMLS CUI [3,1]
C0027651
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0205289
6.1.11.specific criteria for the rfa cohort: single tumor with size of less than 5cm in diameter or tumors 3 or less in number with size of less than 3cm in diameter. the target tumor(s) can be approached by ultrasound guidance.
Description

Criteria Radiofrequency ablation Cohort | Neoplasm Single | Tumor size Diameter | Neoplasms Quantity | Tumor Approach Ultrasonic guidance procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0850292
UMLS CUI [1,3]
C0599755
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0205171
UMLS CUI [3,1]
C0475440
UMLS CUI [3,2]
C1301886
UMLS CUI [4,1]
C0027651
UMLS CUI [4,2]
C1265611
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C0449445
UMLS CUI [5,3]
C0442973
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
6.2.1. chronic hepatitis c. 6.2.2. diffuse or infiltrative pattern of disease. 6.2.3. previous tace procedure for treatment of hcc. 6.2.4. hepatic artery, hepatic vein, or portal venous thrombosis. 6.2.5. history of hcc tumor rupture. 6.2.6. presence of extra-hepatic metastases. 6.2.7. documentation of large intrahepatic or portal-caval shunts. 6.2.8. contraindication for dce-mri, including known contrast allergy, electronically operated implants or devices, and claustrophobia.
Description

Hepatitis C, Chronic | Diffuse Pattern Disease | Pattern Infiltrating Disease | TACE Previous Liver carcinoma | Hepatic artery thrombosis | Hepatic Vein Thrombosis | Portal vein thrombosis | Liver carcinoma Tumour rupture | Metastases Extrahepatic | Shunt intrahepatic | Surgical Portacaval Shunt | Medical contraindication Dynamic contrast-enhanced MRI | Contrast media allergy | Metallic implant | Claustrophobia

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C1333299
UMLS CUI [2,2]
C0012634
UMLS CUI [3,1]
C0449774
UMLS CUI [3,2]
C0332448
UMLS CUI [3,3]
C0012634
UMLS CUI [4,1]
C3539919
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C2239176
UMLS CUI [5]
C0392106
UMLS CUI [6]
C0019154
UMLS CUI [7]
C0155773
UMLS CUI [8,1]
C2239176
UMLS CUI [8,2]
C2938957
UMLS CUI [9,1]
C0027627
UMLS CUI [9,2]
C1517058
UMLS CUI [10,1]
C1442858
UMLS CUI [10,2]
C1512948
UMLS CUI [11]
C0032716
UMLS CUI [12,1]
C1301624
UMLS CUI [12,2]
C1831914
UMLS CUI [13]
C0570562
UMLS CUI [14]
C3693688
UMLS CUI [15]
C0008909
6.2.9. unable to cooperate well with breath holding comments during mri examination or rfa treatment.
Description

Compliance behavior Unable MRI | Compliance behavior Unable Radiofrequency ablation

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C1299582
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C1299582
UMLS CUI [2,3]
C0850292
6.2.10.major systemic diseases that the investigator considers inappropriate for participation.
Description

Systemic disease Major | Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1548788
6.2.11.other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Description

Other medical condition Severe Study Subject Participation Status At risk | Severe Mental Disorders Study Subject Participation Status At risk | Chronic disease Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Other medical condition Severe Study Subject Participation Status Inappropriate | Severe Mental Disorders Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate | Chronic mental disorder Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C1444641
UMLS CUI [2,1]
C4046029
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C1444641
UMLS CUI [4,1]
C0870281
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
UMLS CUI [5,1]
C0438215
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C1444641
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C2348568
UMLS CUI [6,4]
C1548788
UMLS CUI [7,1]
C4046029
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C1548788
UMLS CUI [8,1]
C0008679
UMLS CUI [8,2]
C2348568
UMLS CUI [8,3]
C1548788
UMLS CUI [9,1]
C0870281
UMLS CUI [9,2]
C2348568
UMLS CUI [9,3]
C1548788
UMLS CUI [10,1]
C0438215
UMLS CUI [10,2]
C2348568
UMLS CUI [10,3]
C1548788
6.2.12.coagulation abnormality, including platelet count < 50000/l, prolongation of prothrombin time 5 seconds or inr >1.5) which could not be corrected by component therapy.
Description

Abnormality of coagulation | Platelet Count measurement | Prothrombin time increased | International Normalized Ratio

Data type

boolean

Alias
UMLS CUI [1]
C1846821
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0151872
UMLS CUI [4]
C0525032
6.2.13.obvious ascites which possibly cause bleeding complication. 6.2.14.history or clinically significant cardiac arrhythmia that is considered risky for invasive procedures including tace or rfa.
Description

Ascites At risk Bleeding Complication | Cardiac Arrhythmia At risk Invasive procedure | Cardiac Arrhythmia At risk TACE | Cardiac Arrhythmia At risk Radiofrequency ablation

Data type

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0019080
UMLS CUI [1,4]
C0009566
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C4048276
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C3539919
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0850292
6.2.15.woman who are pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Hepatocellular Carcinoma NCT01281683

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Liver carcinoma | Tumor size | Liver Cirrhosis Imaging study | Hypervascular Phase Arterial | Washout Phase Portal vein | Washout Phase Delayed | Tumor Biopsy
Item
6.1.1. hcc diagnosed according to the aasld guideline1: tumor size > 1cm in a cirrhotic liver with typical appearance in one dynamic imaging study (hypervascular in the arterial phase with washout in the portal venous or delayed phase), or the tumor is biopsied.
boolean
C2239176 (UMLS CUI [1])
C0475440 (UMLS CUI [2])
C0023890 (UMLS CUI [3,1])
C1881134 (UMLS CUI [3,2])
C1512560 (UMLS CUI [4,1])
C0205390 (UMLS CUI [4,2])
C0221464 (UMLS CUI [4,3])
C1710661 (UMLS CUI [5,1])
C0205390 (UMLS CUI [5,2])
C0032718 (UMLS CUI [5,3])
C1710661 (UMLS CUI [6,1])
C0205390 (UMLS CUI [6,2])
C0205421 (UMLS CUI [6,3])
C0027651 (UMLS CUI [7,1])
C0005558 (UMLS CUI [7,2])
Operative Surgical Procedure Liver carcinoma | Measurable lesion Quantity | Age | Hepatitis B, Chronic | ECOG performance status | Life Expectancy | Child-Pugh Classification | Liver function Child-Pugh - Total Score | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement | Creatinine measurement, serum
Item
6.1.2. patients who had undergone surgery for the treatment of hcc are allowed. 6.1.3. at least one measurable tumor, according to recist version 1.1. 6.1.4. age 18 years. 6.1.5. chronic hepatitis b. 6.1.6. ecog performance status 0 or 1. 6.1.7. life expectancy 2 months. 6.1.8. child-pugh class a or b liver function with a child-pugh score of ≦ 8. 6.1.9. liver transaminases (alt and ast) 300 iu/l; total bilirubin 2 mg/dl; serum creatinine 2 mg/dl.
boolean
C0543467 (UMLS CUI [1,1])
C2239176 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0524909 (UMLS CUI [4])
C1520224 (UMLS CUI [5])
C0023671 (UMLS CUI [6])
C2347612 (UMLS CUI [7])
C0232741 (UMLS CUI [8,1])
C4055253 (UMLS CUI [8,2])
C0201836 (UMLS CUI [9])
C0201899 (UMLS CUI [10])
C1278039 (UMLS CUI [11])
C0201976 (UMLS CUI [12])
Criteria TACE Cohort | Neoplasms Lobe Single | Neoplasm Diameter Maximal
Item
6.1.10.specific criteria for the tace cohort: tumors distributed within one lobe and with maximal diameter of 10cm (for adequate amount of non-tumorous liver parenchyma for evaluation).
boolean
C0243161 (UMLS CUI [1,1])
C3539919 (UMLS CUI [1,2])
C0599755 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0796494 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0027651 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0205289 (UMLS CUI [3,3])
Criteria Radiofrequency ablation Cohort | Neoplasm Single | Tumor size Diameter | Neoplasms Quantity | Tumor Approach Ultrasonic guidance procedure
Item
6.1.11.specific criteria for the rfa cohort: single tumor with size of less than 5cm in diameter or tumors 3 or less in number with size of less than 3cm in diameter. the target tumor(s) can be approached by ultrasound guidance.
boolean
C0243161 (UMLS CUI [1,1])
C0850292 (UMLS CUI [1,2])
C0599755 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
C0475440 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0027651 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0027651 (UMLS CUI [5,1])
C0449445 (UMLS CUI [5,2])
C0442973 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Hepatitis C, Chronic | Diffuse Pattern Disease | Pattern Infiltrating Disease | TACE Previous Liver carcinoma | Hepatic artery thrombosis | Hepatic Vein Thrombosis | Portal vein thrombosis | Liver carcinoma Tumour rupture | Metastases Extrahepatic | Shunt intrahepatic | Surgical Portacaval Shunt | Medical contraindication Dynamic contrast-enhanced MRI | Contrast media allergy | Metallic implant | Claustrophobia
Item
6.2.1. chronic hepatitis c. 6.2.2. diffuse or infiltrative pattern of disease. 6.2.3. previous tace procedure for treatment of hcc. 6.2.4. hepatic artery, hepatic vein, or portal venous thrombosis. 6.2.5. history of hcc tumor rupture. 6.2.6. presence of extra-hepatic metastases. 6.2.7. documentation of large intrahepatic or portal-caval shunts. 6.2.8. contraindication for dce-mri, including known contrast allergy, electronically operated implants or devices, and claustrophobia.
boolean
C0524910 (UMLS CUI [1])
C1333299 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0449774 (UMLS CUI [3,1])
C0332448 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
C3539919 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C2239176 (UMLS CUI [4,3])
C0392106 (UMLS CUI [5])
C0019154 (UMLS CUI [6])
C0155773 (UMLS CUI [7])
C2239176 (UMLS CUI [8,1])
C2938957 (UMLS CUI [8,2])
C0027627 (UMLS CUI [9,1])
C1517058 (UMLS CUI [9,2])
C1442858 (UMLS CUI [10,1])
C1512948 (UMLS CUI [10,2])
C0032716 (UMLS CUI [11])
C1301624 (UMLS CUI [12,1])
C1831914 (UMLS CUI [12,2])
C0570562 (UMLS CUI [13])
C3693688 (UMLS CUI [14])
C0008909 (UMLS CUI [15])
Compliance behavior Unable MRI | Compliance behavior Unable Radiofrequency ablation
Item
6.2.9. unable to cooperate well with breath holding comments during mri examination or rfa treatment.
boolean
C1321605 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0850292 (UMLS CUI [2,3])
Systemic disease Major | Study Subject Participation Status Inappropriate
Item
6.2.10.major systemic diseases that the investigator considers inappropriate for participation.
boolean
C0442893 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C1548788 (UMLS CUI [2,2])
Other medical condition Severe Study Subject Participation Status At risk | Severe Mental Disorders Study Subject Participation Status At risk | Chronic disease Study Subject Participation Status At risk | Chronic mental disorder Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Other medical condition Severe Study Subject Participation Status Inappropriate | Severe Mental Disorders Study Subject Participation Status Inappropriate | Chronic disease Study Subject Participation Status Inappropriate | Chronic mental disorder Study Subject Participation Status Inappropriate | Laboratory test result abnormal Study Subject Participation Status Inappropriate
Item
6.2.11.other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
C4046029 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0008679 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C1444641 (UMLS CUI [3,3])
C0870281 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0438215 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C1548788 (UMLS CUI [6,4])
C4046029 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C1548788 (UMLS CUI [7,3])
C0008679 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C1548788 (UMLS CUI [8,3])
C0870281 (UMLS CUI [9,1])
C2348568 (UMLS CUI [9,2])
C1548788 (UMLS CUI [9,3])
C0438215 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C1548788 (UMLS CUI [10,3])
Abnormality of coagulation | Platelet Count measurement | Prothrombin time increased | International Normalized Ratio
Item
6.2.12.coagulation abnormality, including platelet count < 50000/l, prolongation of prothrombin time 5 seconds or inr >1.5) which could not be corrected by component therapy.
boolean
C1846821 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0151872 (UMLS CUI [3])
C0525032 (UMLS CUI [4])
Ascites At risk Bleeding Complication | Cardiac Arrhythmia At risk Invasive procedure | Cardiac Arrhythmia At risk TACE | Cardiac Arrhythmia At risk Radiofrequency ablation
Item
6.2.13.obvious ascites which possibly cause bleeding complication. 6.2.14.history or clinically significant cardiac arrhythmia that is considered risky for invasive procedures including tace or rfa.
boolean
C0003962 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
C0009566 (UMLS CUI [1,4])
C0003811 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C4048276 (UMLS CUI [2,3])
C0003811 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C3539919 (UMLS CUI [3,3])
C0003811 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0850292 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
6.2.15.woman who are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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