ID

19048

Description

[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00588185

Link

https://clinicaltrials.gov/show/NCT00588185

Keywords

Versions (1)
  1. 12/1/16 12/1/16 -
Uploaded on

December 1, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Prostate Cancer NCT00588185

English

Eligibility Prostate Cancer NCT00588185

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed prostate cancer.
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
progressive disease manifest by either:
Description

Progressive Disease

Data type

boolean

Alias
UMLS CUI [1]
C1335499
imaging modalities:
Description

Imaging Techniques

Data type

boolean

Alias
UMLS CUI [1]
C0079595
bone imaging: new osseous lesions on bone imaging (bone scintigraphy or naf pet scan) and/or mri or ct: an increase in measurable soft tissue disease, or the appearance of new sites of disease. or
Description

Bone imaging | Bone lesion Bone scintigraphy | Bone lesion F-18 Sodium Fluoride Positron Emission Tomography | Bone lesion Magnetic Resonance Imaging | Bone lesion X-Ray Computed Tomography | Measurable Disease soft tissue Increase | Disease Site New

Data type

boolean

Alias
UMLS CUI [1]
C0203668
UMLS CUI [2,1]
C0238792
UMLS CUI [2,2]
C3889015
UMLS CUI [3,1]
C0238792
UMLS CUI [3,2]
C2985493
UMLS CUI [4,1]
C0238792
UMLS CUI [4,2]
C0024485
UMLS CUI [5,1]
C0238792
UMLS CUI [5,2]
C0040405
UMLS CUI [6,1]
C1513041
UMLS CUI [6,2]
C0225317
UMLS CUI [6,3]
C0442805
UMLS CUI [7,1]
C0012634
UMLS CUI [7,2]
C1515974
UMLS CUI [7,3]
C0205314
biochemical progression: a minimum of three rising psa values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart.
Description

Disease Progression Biochemical | Raised prostate specific antigen Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0205474
UMLS CUI [2,1]
C0178415
UMLS CUI [2,2]
C1265611
visible lesions by either ct, bone imaging, or mri consistent with disease.
Description

Visible Lesion X-Ray Computed Tomography Consistent with Disease | Visible Lesion Bone imaging Consistent with Disease | Visible Lesion Magnetic Resonance Imaging Consistent with Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0040405
UMLS CUI [1,3]
C0332290
UMLS CUI [1,4]
C0012634
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0203668
UMLS CUI [2,3]
C0332290
UMLS CUI [2,4]
C0012634
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0024485
UMLS CUI [3,3]
C0332290
UMLS CUI [3,4]
C0012634
informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous anaphylactic reaction to either fdht or fdg
Description

anaphylaxis 18F-FDHT | anaphylaxis FDG

Data type

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C3827004
UMLS CUI [2,1]
C0002792
UMLS CUI [2,2]
C0046056
hepatic: bilirubin > 1.5 x upper limit of normal (uln), ast/alt >2.5 x uln, albumin < 2 g/dl, and ggt > 2.5 x uln if alkaline phosphatase > 2.5 x uln
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Albumin measurement | Gamma glutamyl transferase measurement | Alkaline phosphatase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201838
UMLS CUI [6]
C0202035
UMLS CUI [7]
C0201850
renal: creatinine >1.5 x uln or creatinine clearance < 60 ml/min
Description

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
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Similar models

Eligibility Prostate Cancer NCT00588185

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Prostate carcinoma
Item
patients with histologically confirmed prostate cancer.
boolean
C0600139 (UMLS CUI [1])
Progressive Disease
Item
progressive disease manifest by either:
boolean
C1335499 (UMLS CUI [1])
Imaging Techniques
Item
imaging modalities:
boolean
C0079595 (UMLS CUI [1])
Bone imaging | Bone lesion Bone scintigraphy | Bone lesion F-18 Sodium Fluoride Positron Emission Tomography | Bone lesion Magnetic Resonance Imaging | Bone lesion X-Ray Computed Tomography | Measurable Disease soft tissue Increase | Disease Site New
Item
bone imaging: new osseous lesions on bone imaging (bone scintigraphy or naf pet scan) and/or mri or ct: an increase in measurable soft tissue disease, or the appearance of new sites of disease. or
boolean
C0203668 (UMLS CUI [1])
C0238792 (UMLS CUI [2,1])
C3889015 (UMLS CUI [2,2])
C0238792 (UMLS CUI [3,1])
C2985493 (UMLS CUI [3,2])
C0238792 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C0238792 (UMLS CUI [5,1])
C0040405 (UMLS CUI [5,2])
C1513041 (UMLS CUI [6,1])
C0225317 (UMLS CUI [6,2])
C0442805 (UMLS CUI [6,3])
C0012634 (UMLS CUI [7,1])
C1515974 (UMLS CUI [7,2])
C0205314 (UMLS CUI [7,3])
Disease Progression Biochemical | Raised prostate specific antigen Quantity
Item
biochemical progression: a minimum of three rising psa values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart.
boolean
C0242656 (UMLS CUI [1,1])
C0205474 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Visible Lesion X-Ray Computed Tomography Consistent with Disease | Visible Lesion Bone imaging Consistent with Disease | Visible Lesion Magnetic Resonance Imaging Consistent with Disease
Item
visible lesions by either ct, bone imaging, or mri consistent with disease.
boolean
C0221198 (UMLS CUI [1,1])
C0040405 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
C0221198 (UMLS CUI [2,1])
C0203668 (UMLS CUI [2,2])
C0332290 (UMLS CUI [2,3])
C0012634 (UMLS CUI [2,4])
C0221198 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
C0332290 (UMLS CUI [3,3])
C0012634 (UMLS CUI [3,4])
Informed Consent
Item
informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
anaphylaxis 18F-FDHT | anaphylaxis FDG
Item
previous anaphylactic reaction to either fdht or fdg
boolean
C0002792 (UMLS CUI [1,1])
C3827004 (UMLS CUI [1,2])
C0002792 (UMLS CUI [2,1])
C0046056 (UMLS CUI [2,2])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Albumin measurement | Gamma glutamyl transferase measurement | Alkaline phosphatase measurement
Item
hepatic: bilirubin > 1.5 x upper limit of normal (uln), ast/alt >2.5 x uln, albumin < 2 g/dl, and ggt > 2.5 x uln if alkaline phosphatase > 2.5 x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201838 (UMLS CUI [5])
C0202035 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
renal: creatinine >1.5 x uln or creatinine clearance < 60 ml/min
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
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