ID

39313

Beschreibung

Open-label, Non-randomized Study to Assess Safety, Bio-distribution, and Radiation Dosimetry, and Optimize the Imaging Protocol of GEH120714 (18F) Injection in Healthy Volunteers and Participants With Relapsing and Remitting Multiple Sclerosis (rrMS).; ODM derived from: https://clinicaltrials.gov/show/NCT01738347

Link

https://clinicaltrials.gov/show/NCT01738347

Stichworte

Versionen (1)
  1. 18.12.19 18.12.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

18. Dezember 2019

DOI

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Creative Commons BY 4.0
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Eligibility Evaluate the Safety of GEH120714 (18F) Injection in Healthy Volunteers (HV) and Participants With rrMS. NCT01738347

Englisch

Eligibility Evaluate the Safety of GEH120714 (18F) Injection in Healthy Volunteers (HV) and Participants With rrMS. NCT01738347

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
inclusion criteria for all participants:
Beschreibung

Inclusion criteria Study Subject All

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C0444868
the subject has a clinically normal or acceptable medical history and physical examination at screening.
Beschreibung

Medical History Normal | Physical Examination Normal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C0205307
the subject has an acceptable kidney function (egfr >60 ml/min/1.73m2) for administration of gadolinium.
Beschreibung

Renal function | Estimated Glomerular Filtration Rate | Administration Gadolinium

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C3811844
UMLS CUI [3,1]
C1533734
UMLS CUI [3,2]
C0016911
the subject has a trans-locator protein (tspo) platelet assay conducted with documented results.
Beschreibung

TSPO protein Platelet Assay

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1528023
UMLS CUI [1,2]
C0005821
UMLS CUI [1,3]
C1510438
inclusion criteria for all healthy volunteers:
Beschreibung

Inclusion criteria Healthy Volunteers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1708335
the subject has no clinical history or signs of neurological impairment.
Beschreibung

Neurologic Deficits Absent | Signs Absent Neurologic Deficits

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0521654
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0311392
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0521654
the subject has a normal mri without central white white matter lesions.
Beschreibung

MRI normal | White matter lesion Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0436481
UMLS CUI [2,1]
C2752009
UMLS CUI [2,2]
C0332197
inclusion criteria specific for participants with relapsing and remitting results sclerosis (rrms):
Beschreibung

Inclusion criteria Relapsing-Remitting Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0751967
subject with a previous diagnosis of rrms, presenting with (a) clinically active disease at time of screening or, or preferentially, (b) clinically active disease at time of screening and having at least one gadolinium--enhanced lesion on mri.
Beschreibung

Multiple Sclerosis, Relapsing-Remitting | Lesion Quantity Nuclear magnetic resonance imaging gadolinium-enhanced

Datentyp

boolean

Alias
UMLS CUI [1]
C0751967
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0855566
the subject at screening has a mri scan of sufficient quality for volume of interest (voi) definition and co-alignment with positron emission tomography (pet).
Beschreibung

MRI scan Appropriate Volume of Interest Determination | MRI scan Appropriate Alignment Positron-Emission Tomography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C2986837
UMLS CUI [1,4]
C1148554
UMLS CUI [2,1]
C0024485
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C1706765
UMLS CUI [2,4]
C0032743
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
general exclusion criteria for all participants:
Beschreibung

Exclusion Criteria Patients All

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0444868
the subject has a contraindication for magnetic resonance imaging (mri).
Beschreibung

Medical contraindication Magnetic Resonance Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
the subject has known allergies to gadolinium contrast agent.
Beschreibung

Hypersensitivity Gadolinium-based Contrast Agent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3249258
the subject has received significant ionising radiation exposure from clinical trials or medical examinations in the last 12 months.
Beschreibung

Exposure to ionizing radiation

Datentyp

boolean

Alias
UMLS CUI [1]
C0479513
exclusion criteria specific for healthy volunteers:
Beschreibung

Exclusion Criteria Healthy Volunteers

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1708335
the subject has family history of multiple sclerosis (ms).
Beschreibung

Family history of Multiple sclerosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0455388
the subject is undergoing monitoring of occupational ionising radiation exposure.
Beschreibung

Monitoring Exposure to ionizing radiation Occupational

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034532
UMLS CUI [1,2]
C0479513
UMLS CUI [1,3]
C0521127
exclusion criteria specific for participants with remitting multiple sclerosis (rrms):
Beschreibung

Exclusion Criteria Relapsing-Remitting Multiple Sclerosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0751967
the subject has a past history of cerebrovascular disease or vasculitis.
Beschreibung

Cerebrovascular Disorder | Vasculitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0007820
UMLS CUI [2]
C0042384
the subject has a history of head injury with prolonged coma.
Beschreibung

Craniocerebral Trauma with Prolonged coma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018674
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C1385283
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Ähnliche Modelle

Eligibility Evaluate the Safety of GEH120714 (18F) Injection in Healthy Volunteers (HV) and Participants With rrMS. NCT01738347

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria Study Subject All
Item
inclusion criteria for all participants:
boolean
C1512693 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
Medical History Normal | Physical Examination Normal
Item
the subject has a clinically normal or acceptable medical history and physical examination at screening.
boolean
C0262926 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Renal function | Estimated Glomerular Filtration Rate | Administration Gadolinium
Item
the subject has an acceptable kidney function (egfr >60 ml/min/1.73m2) for administration of gadolinium.
boolean
C0232804 (UMLS CUI [1])
C3811844 (UMLS CUI [2])
C1533734 (UMLS CUI [3,1])
C0016911 (UMLS CUI [3,2])
TSPO protein Platelet Assay
Item
the subject has a trans-locator protein (tspo) platelet assay conducted with documented results.
boolean
C1528023 (UMLS CUI [1,1])
C0005821 (UMLS CUI [1,2])
C1510438 (UMLS CUI [1,3])
Inclusion criteria Healthy Volunteers
Item
inclusion criteria for all healthy volunteers:
boolean
C1512693 (UMLS CUI [1,1])
C1708335 (UMLS CUI [1,2])
Neurologic Deficits Absent | Signs Absent Neurologic Deficits
Item
the subject has no clinical history or signs of neurological impairment.
boolean
C0521654 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0311392 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0521654 (UMLS CUI [2,3])
MRI normal | White matter lesion Absent
Item
the subject has a normal mri without central white white matter lesions.
boolean
C0436481 (UMLS CUI [1])
C2752009 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Inclusion criteria Relapsing-Remitting Multiple Sclerosis
Item
inclusion criteria specific for participants with relapsing and remitting results sclerosis (rrms):
boolean
C1512693 (UMLS CUI [1,1])
C0751967 (UMLS CUI [1,2])
Multiple Sclerosis, Relapsing-Remitting | Lesion Quantity Nuclear magnetic resonance imaging gadolinium-enhanced
Item
subject with a previous diagnosis of rrms, presenting with (a) clinically active disease at time of screening or, or preferentially, (b) clinically active disease at time of screening and having at least one gadolinium--enhanced lesion on mri.
boolean
C0751967 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0855566 (UMLS CUI [2,3])
MRI scan Appropriate Volume of Interest Determination | MRI scan Appropriate Alignment Positron-Emission Tomography
Item
the subject at screening has a mri scan of sufficient quality for volume of interest (voi) definition and co-alignment with positron emission tomography (pet).
boolean
C0024485 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C2986837 (UMLS CUI [1,3])
C1148554 (UMLS CUI [1,4])
C0024485 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C1706765 (UMLS CUI [2,3])
C0032743 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Patients All
Item
general exclusion criteria for all participants:
boolean
C0680251 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0444868 (UMLS CUI [1,3])
Medical contraindication Magnetic Resonance Imaging
Item
the subject has a contraindication for magnetic resonance imaging (mri).
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Hypersensitivity Gadolinium-based Contrast Agent
Item
the subject has known allergies to gadolinium contrast agent.
boolean
C0020517 (UMLS CUI [1,1])
C3249258 (UMLS CUI [1,2])
Exposure to ionizing radiation
Item
the subject has received significant ionising radiation exposure from clinical trials or medical examinations in the last 12 months.
boolean
C0479513 (UMLS CUI [1])
Exclusion Criteria Healthy Volunteers
Item
exclusion criteria specific for healthy volunteers:
boolean
C0680251 (UMLS CUI [1,1])
C1708335 (UMLS CUI [1,2])
Family history of Multiple sclerosis
Item
the subject has family history of multiple sclerosis (ms).
boolean
C0455388 (UMLS CUI [1])
Monitoring Exposure to ionizing radiation Occupational
Item
the subject is undergoing monitoring of occupational ionising radiation exposure.
boolean
C0034532 (UMLS CUI [1,1])
C0479513 (UMLS CUI [1,2])
C0521127 (UMLS CUI [1,3])
Exclusion Criteria Relapsing-Remitting Multiple Sclerosis
Item
exclusion criteria specific for participants with remitting multiple sclerosis (rrms):
boolean
C0680251 (UMLS CUI [1,1])
C0751967 (UMLS CUI [1,2])
Cerebrovascular Disorder | Vasculitis
Item
the subject has a past history of cerebrovascular disease or vasculitis.
boolean
C0007820 (UMLS CUI [1])
C0042384 (UMLS CUI [2])
Craniocerebral Trauma with Prolonged coma
Item
the subject has a history of head injury with prolonged coma.
boolean
C0018674 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C1385283 (UMLS CUI [1,3])
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