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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01092546 |
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Date of registration:
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23/03/2010 |
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Primary sponsor: |
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Public title:
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Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
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Scientific title:
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A Principal, Prospective, Open-label Biopsy Study to Validate Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in NPH Subjects. |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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12 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01092546 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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United States
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Contacts
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Name:
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Kim A Mansfield, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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GE Healthcare |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The subject is at least 50 years of age.
- The subjects' general health is adequate to comply with study procedures.
- The subject has been scheduled for a shunt placement procedure for the treatment
of NPH.
Exclusion Criteria:
- The subject has a contraindication for MRI or PET.
- The subject is pregnant or lactating.
- The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or
to any of the excipients.
- The subject has participated in any clinical study using an investigational agent
within 30 days of dosing.
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Normal Pressure Hydrocephalus
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Intervention(s)
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Drug: [18F]Flutemetamol
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Primary Outcome(s)
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Brain uptake of [18F]flutemetamol
[Time Frame: Time zero equals the date of PET imaging. A follow-up phone call approximately 24 hours after the [18F]flutemetamol will be made to assess potential adverse events (AEs).]
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Secondary Outcome(s)
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Level of association between SUVR and the quantitative estimates of amyloid levels
[Time Frame: Time zero equals the date of PET imaging. A follow-up phone call approximately 24 hours after the [18F]flutemetamol will be made to assess potential adverse events (AEs).]
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Secondary ID(s)
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GE-067-009
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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