ID

36066

Beskrivning

To Evaluate the Efficacy and Safety of (18F-FCH) Comparing With (18F-FDG) for Detecting Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02074202

Länk

https://clinicaltrials.gov/show/NCT02074202

Nyckelord

Versioner (1)
  1. 2019-04-12 2019-04-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatocellular Carcinoma NCT02074202

Engelsk

Eligibility Hepatocellular Carcinoma NCT02074202

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female, age ≥ 20 years old.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. patient who accepts to enter the study by signing written informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
3. patient with performance status ≤ 2 eastern cooperative oncology group (ecog).
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. patient with cirrhosis or chronic liver diseases suspected to have at least 1 hepatic nodule larger than 1 cm in diameter detected by conventional image (us, ct, mri). patient who has not yet received any therapy relevant to the aforementioned diagnosis. hepatic nodule is defined as any one of the following conditions: suspicious hepatocellular carcinoma, benign tumor such as hemangioma, adenoma or focal nodular hyperplasia, metastatic lesions from other primary malignancy.
Beskrivning

Liver Cirrhosis | Chronic liver disease | Nodule of liver Diameter Quantity | Nodule of liver Diameter Ultrasonography | Nodule of liver Diameter Computed Tomography | Nodule of liver Diameter MRI | Patient Therapy naive | Liver carcinoma Suspicious | Benign Neoplasm | Hemangioma | Adenoma | Focal Nodular Hyperplasia | Metastatic Lesion Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0341439
UMLS CUI [3,1]
C0745761
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0745761
UMLS CUI [4,2]
C1301886
UMLS CUI [4,3]
C0041618
UMLS CUI [5,1]
C0745761
UMLS CUI [5,2]
C1301886
UMLS CUI [5,3]
C0040405
UMLS CUI [6,1]
C0745761
UMLS CUI [6,2]
C1301886
UMLS CUI [6,3]
C0024485
UMLS CUI [7,1]
C0030705
UMLS CUI [7,2]
C0919936
UMLS CUI [8,1]
C2239176
UMLS CUI [8,2]
C0750493
UMLS CUI [9]
C0086692
UMLS CUI [10]
C0018916
UMLS CUI [11]
C0001430
UMLS CUI [12]
C0333980
UMLS CUI [13,1]
C1513183
UMLS CUI [13,2]
C1707251
5. female patient must take reliable contraception method(s) during the participation of the study.
Beskrivning

Gender Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patient has serious allergic history or known allergy to 18f-fdg or 18f-fch.
Beskrivning

Hypersensitivity 18F-FDG | Hypersensitivity 18F-FCH

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0046056
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1872806
2. patient has been diagnosed of multiple malignancies.
Beskrivning

Multiple malignancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0346429
3. female patient who is pregnant, lactating or planning to become pregnant during the study.
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
4. patient has been participated in other investigational trials within 28 days prior to study enrollment.
Beskrivning

Study Subject Participation Status | Research study

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0681814
5. patient is unable to undergo pet/ct scan.
Beskrivning

PET/CT scan Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1699633
UMLS CUI [1,2]
C1299582
6. subjects with active systemic infections, or medical conditions that may significantly affect action, adequate uptake and elimination of radiotracer.
Beskrivning

Sepsis | Medical condition Affecting Action Radiotracer | Medical condition Affecting Uptake Radiotracer | Medical condition Affecting Elimination Radiotracer

Datatyp

boolean

Alias
UMLS CUI [1]
C0243026
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C3266814
UMLS CUI [2,4]
C0597354
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0243144
UMLS CUI [3,4]
C0597354
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0221102
UMLS CUI [4,4]
C0597354
7. subject with conditions judged by the investigator as unsuitable for the study.
Beskrivning

Condition Study Subject Participation Status Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
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Similar models

Eligibility Hepatocellular Carcinoma NCT02074202

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female, age ≥ 20 years old.
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. patient who accepts to enter the study by signing written informed consent.
boolean
C0021430 (UMLS CUI [1])
ECOG performance status
Item
3. patient with performance status ≤ 2 eastern cooperative oncology group (ecog).
boolean
C1520224 (UMLS CUI [1])
Liver Cirrhosis | Chronic liver disease | Nodule of liver Diameter Quantity | Nodule of liver Diameter Ultrasonography | Nodule of liver Diameter Computed Tomography | Nodule of liver Diameter MRI | Patient Therapy naive | Liver carcinoma Suspicious | Benign Neoplasm | Hemangioma | Adenoma | Focal Nodular Hyperplasia | Metastatic Lesion Cancer Other
Item
4. patient with cirrhosis or chronic liver diseases suspected to have at least 1 hepatic nodule larger than 1 cm in diameter detected by conventional image (us, ct, mri). patient who has not yet received any therapy relevant to the aforementioned diagnosis. hepatic nodule is defined as any one of the following conditions: suspicious hepatocellular carcinoma, benign tumor such as hemangioma, adenoma or focal nodular hyperplasia, metastatic lesions from other primary malignancy.
boolean
C0023890 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
C0745761 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0745761 (UMLS CUI [4,1])
C1301886 (UMLS CUI [4,2])
C0041618 (UMLS CUI [4,3])
C0745761 (UMLS CUI [5,1])
C1301886 (UMLS CUI [5,2])
C0040405 (UMLS CUI [5,3])
C0745761 (UMLS CUI [6,1])
C1301886 (UMLS CUI [6,2])
C0024485 (UMLS CUI [6,3])
C0030705 (UMLS CUI [7,1])
C0919936 (UMLS CUI [7,2])
C2239176 (UMLS CUI [8,1])
C0750493 (UMLS CUI [8,2])
C0086692 (UMLS CUI [9])
C0018916 (UMLS CUI [10])
C0001430 (UMLS CUI [11])
C0333980 (UMLS CUI [12])
C1513183 (UMLS CUI [13,1])
C1707251 (UMLS CUI [13,2])
Gender Contraceptive methods
Item
5. female patient must take reliable contraception method(s) during the participation of the study.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity 18F-FDG | Hypersensitivity 18F-FCH
Item
1. patient has serious allergic history or known allergy to 18f-fdg or 18f-fch.
boolean
C0020517 (UMLS CUI [1,1])
C0046056 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1872806 (UMLS CUI [2,2])
Multiple malignancy
Item
2. patient has been diagnosed of multiple malignancies.
boolean
C0346429 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
3. female patient who is pregnant, lactating or planning to become pregnant during the study.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status | Research study
Item
4. patient has been participated in other investigational trials within 28 days prior to study enrollment.
boolean
C2348568 (UMLS CUI [1])
C0681814 (UMLS CUI [2])
PET/CT scan Unable
Item
5. patient is unable to undergo pet/ct scan.
boolean
C1699633 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Sepsis | Medical condition Affecting Action Radiotracer | Medical condition Affecting Uptake Radiotracer | Medical condition Affecting Elimination Radiotracer
Item
6. subjects with active systemic infections, or medical conditions that may significantly affect action, adequate uptake and elimination of radiotracer.
boolean
C0243026 (UMLS CUI [1])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C3266814 (UMLS CUI [2,3])
C0597354 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0243144 (UMLS CUI [3,3])
C0597354 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0221102 (UMLS CUI [4,3])
C0597354 (UMLS CUI [4,4])
Condition Study Subject Participation Status Inappropriate
Item
7. subject with conditions judged by the investigator as unsuitable for the study.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
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