ID

37193

Beschreibung

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology; ODM derived from: https://clinicaltrials.gov/show/NCT01886820 To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology

Link

https://clinicaltrials.gov/show/NCT01886820

Stichworte

Versionen (1)
  1. 07.07.19 07.07.19 -
Rechteinhaber

Navidea Biopharmaceuticals

Hochgeladen am

7. Juli 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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[18F]NAV4694 PET for Beta-Amyloid Detection NCT01886820

Englisch

Eligibility Criteria

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
Is the participant a male or female subjects and will be at least 21 years of age?
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Does the participant have a life expectancy of approximately 6 months?
Beschreibung

Life expectancy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439801
Is the participants health adequate as determined by the investigator to receive [18f]nav4694?
Beschreibung

Adequate Health

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205411
UMLS CUI [1,2]
C0018684
UMLS CUI [1,3]
C0013230
Is the (female) participant not of child-bearing potential or will have a negative urine pregnancy test on the day of [18f]nav4694 injection?
Beschreibung

No childbearing potential or negative pregnancy test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1705492
UMLS CUI [1,2]
C3831118
UMLS CUI [2,1]
C0430057
UMLS CUI [2,2]
C0439228
UMLS CUI [2,3]
C1533734
UMLS CUI [2,4]
C0162778
Does the participant exhibit adequate visual, auditory, and communication capabilities to enable compliance with study procedures? (this includes being able to lie down flat in the MRI or CT and PET scanner for a period of approximately 1 hour)
Beschreibung

Capability to comply

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205411
UMLS CUI [1,2]
C0234621
UMLS CUI [1,3]
C3714738
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C0205411
UMLS CUI [2,2]
C0439825
UMLS CUI [2,3]
C3714738
UMLS CUI [2,4]
C2348563
UMLS CUI [3,1]
C0205411
UMLS CUI [3,2]
C0009452
UMLS CUI [3,3]
C3714738
UMLS CUI [3,4]
C2348563
UMLS CUI [4,1]
C2584317
UMLS CUI [4,2]
C0024485
UMLS CUI [5,1]
C2584317
UMLS CUI [5,2]
C0040405
UMLS CUI [6,1]
C2584317
UMLS CUI [6,2]
C0032743
Is the participant willing to donate his/her brain for post mortem examination upon death? (this consent can be obtained in the manner specific to the country/region involved).
Beschreibung

Post mortem brain donation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586890
UMLS CUI [1,2]
C0006104
UMLS CUI [1,3]
C0004398
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0454664
UMLS CUI [2,3]
C0205369
Has the participant been fully informed about the study, including provisions of the health insurance portability and accountability act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative (lar) (for individuals with dementia)?
Beschreibung

Fully informed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0443225
UMLS CUI [1,2]
C1533716
UMLS CUI [1,3]
C2603343
UMLS CUI [1,4]
C0600593
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0807937
UMLS CUI [2,3]
C0030705
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C0807937
UMLS CUI [3,3]
C0030705
UMLS CUI [3,4]
C0023226
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
Is the participant scheduled for surgery and/or another invasive procedure within the time period of up to 7 days after [18f]nav4694 injection?
Beschreibung

Scheduled for invasive procedure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3242215
UMLS CUI [1,2]
C4018905
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C4048276
UMLS CUI [2,2]
C0205539
UMLS CUI [2,3]
C4018905
UMLS CUI [2,4]
C0687676
UMLS CUI [2,5]
C0013230
Does the participant have severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by mri that prohibits sampling of the required pre-specified ROIs?
Beschreibung

Macrovascular disease or tumor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006104
UMLS CUI [1,2]
C2609253
UMLS CUI [1,3]
C0024485
UMLS CUI [1,4]
C0521102
UMLS CUI [1,5]
C0870078
UMLS CUI [1,6]
C0807727
UMLS CUI [2,1]
C0006118
UMLS CUI [2,2]
C0024485
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0870078
UMLS CUI [2,5]
C0807727
Does the participant have any history of any transmissible spongiform encephalopathy (prion disease)?
Beschreibung

Prion disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0162534
Has the participant received any contrast material (x-ray, mri) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131-i) within 10 days prior to, or any radiopharmaceutical administration within 10 radioactive half-lives prior to the administration of the investigational product or for whom administration of such substances is planned within 7 days after investigational product administration?
Beschreibung

Radiopharmaceutical administered

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348003
UMLS CUI [1,2]
C0009924
UMLS CUI [1,3]
C4018905
UMLS CUI [1,4]
C0687676
UMLS CUI [1,5]
C0162778
UMLS CUI [2,1]
C2348003
UMLS CUI [2,2]
C0182638
UMLS CUI [2,3]
C4018905
UMLS CUI [2,4]
C0687676
UMLS CUI [2,5]
C0162778
UMLS CUI [3,1]
C2348003
UMLS CUI [3,2]
C1145010
UMLS CUI [3,3]
C4018905
UMLS CUI [3,4]
C0687676
UMLS CUI [3,5]
C0162778
UMLS CUI [4,1]
C2348003
UMLS CUI [4,2]
C0009924
UMLS CUI [4,3]
C4018905
UMLS CUI [4,4]
C0332152
UMLS CUI [4,5]
C0162778
UMLS CUI [5,1]
C2348003
UMLS CUI [5,2]
C0182638
UMLS CUI [5,3]
C4018905
UMLS CUI [5,4]
C0332152
UMLS CUI [5,5]
C0162778
UMLS CUI [6,1]
C2348003
UMLS CUI [6,2]
C1145010
UMLS CUI [6,3]
C4018905
UMLS CUI [6,4]
C0332152
UMLS CUI [6,5]
C0162778
Is the participabt allergic to the investigational product or any of its constituents?
Beschreibung

Allergy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700624
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0700624
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0729650
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Ähnliche Modelle

Eligibility Criteria

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Is the participant a male or female subjects and will be at least 21 years of age?
boolean
C0001779 (UMLS CUI [1])
Life expectancy
Item
Does the participant have a life expectancy of approximately 6 months?
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Adequate Health
Item
Is the participants health adequate as determined by the investigator to receive [18f]nav4694?
boolean
C0205411 (UMLS CUI [1,1])
C0018684 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
No childbearing potential or negative pregnancy test
Item
Is the (female) participant not of child-bearing potential or will have a negative urine pregnancy test on the day of [18f]nav4694 injection?
boolean
C1705492 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0430057 (UMLS CUI [2,1])
C0439228 (UMLS CUI [2,2])
C1533734 (UMLS CUI [2,3])
C0162778 (UMLS CUI [2,4])
Capability to comply
Item
Does the participant exhibit adequate visual, auditory, and communication capabilities to enable compliance with study procedures? (this includes being able to lie down flat in the MRI or CT and PET scanner for a period of approximately 1 hour)
boolean
C0205411 (UMLS CUI [1,1])
C0234621 (UMLS CUI [1,2])
C3714738 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0205411 (UMLS CUI [2,1])
C0439825 (UMLS CUI [2,2])
C3714738 (UMLS CUI [2,3])
C2348563 (UMLS CUI [2,4])
C0205411 (UMLS CUI [3,1])
C0009452 (UMLS CUI [3,2])
C3714738 (UMLS CUI [3,3])
C2348563 (UMLS CUI [3,4])
C2584317 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
C2584317 (UMLS CUI [5,1])
C0040405 (UMLS CUI [5,2])
C2584317 (UMLS CUI [6,1])
C0032743 (UMLS CUI [6,2])
Post mortem brain donation
Item
Is the participant willing to donate his/her brain for post mortem examination upon death? (this consent can be obtained in the manner specific to the country/region involved).
boolean
C0586890 (UMLS CUI [1,1])
C0006104 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
C0021430 (UMLS CUI [2,1])
C0454664 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
Fully informed
Item
Has the participant been fully informed about the study, including provisions of the health insurance portability and accountability act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative (lar) (for individuals with dementia)?
boolean
C0443225 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
C0600593 (UMLS CUI [1,4])
C0021430 (UMLS CUI [2,1])
C0807937 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3,1])
C0807937 (UMLS CUI [3,2])
C0030705 (UMLS CUI [3,3])
C0023226 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Scheduled for invasive procedure
Item
Is the participant scheduled for surgery and/or another invasive procedure within the time period of up to 7 days after [18f]nav4694 injection?
boolean
C3242215 (UMLS CUI [1,1])
C4018905 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C4048276 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C4018905 (UMLS CUI [2,3])
C0687676 (UMLS CUI [2,4])
C0013230 (UMLS CUI [2,5])
Macrovascular disease or tumor
Item
Does the participant have severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by mri that prohibits sampling of the required pre-specified ROIs?
boolean
C0006104 (UMLS CUI [1,1])
C2609253 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0521102 (UMLS CUI [1,4])
C0870078 (UMLS CUI [1,5])
C0807727 (UMLS CUI [1,6])
C0006118 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0870078 (UMLS CUI [2,4])
C0807727 (UMLS CUI [2,5])
Prion disease
Item
Does the participant have any history of any transmissible spongiform encephalopathy (prion disease)?
boolean
C0262926 (UMLS CUI [1,1])
C0162534 (UMLS CUI [1,2])
Radiopharmaceutical administered
Item
Has the participant received any contrast material (x-ray, mri) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131-i) within 10 days prior to, or any radiopharmaceutical administration within 10 radioactive half-lives prior to the administration of the investigational product or for whom administration of such substances is planned within 7 days after investigational product administration?
boolean
C2348003 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
C4018905 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0162778 (UMLS CUI [1,5])
C2348003 (UMLS CUI [2,1])
C0182638 (UMLS CUI [2,2])
C4018905 (UMLS CUI [2,3])
C0687676 (UMLS CUI [2,4])
C0162778 (UMLS CUI [2,5])
C2348003 (UMLS CUI [3,1])
C1145010 (UMLS CUI [3,2])
C4018905 (UMLS CUI [3,3])
C0687676 (UMLS CUI [3,4])
C0162778 (UMLS CUI [3,5])
C2348003 (UMLS CUI [4,1])
C0009924 (UMLS CUI [4,2])
C4018905 (UMLS CUI [4,3])
C0332152 (UMLS CUI [4,4])
C0162778 (UMLS CUI [4,5])
C2348003 (UMLS CUI [5,1])
C0182638 (UMLS CUI [5,2])
C4018905 (UMLS CUI [5,3])
C0332152 (UMLS CUI [5,4])
C0162778 (UMLS CUI [5,5])
C2348003 (UMLS CUI [6,1])
C1145010 (UMLS CUI [6,2])
C4018905 (UMLS CUI [6,3])
C0332152 (UMLS CUI [6,4])
C0162778 (UMLS CUI [6,5])
Allergy
Item
Is the participabt allergic to the investigational product or any of its constituents?
boolean
C0700624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0700624 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0729650 (UMLS CUI [2,3])
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