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Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

This study has been terminated.
(Changed focus of the program)
Sponsor:
Collaborator:
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01092546
First received: March 23, 2010
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

To determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement for NPH.


Condition Intervention Phase
Normal Pressure Hydrocephalus
 Drug: [18F]Flutemetamol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Principal, Prospective, Open-label Biopsy Study to Validate Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in NPH Subjects.

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    Determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples obtained during shunt placement in patients who have NPH. The quantitative estimates of brain uptake of [18F]flutemetamol (SUVR) will be made from the analysis of PET images.


Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    To determine the level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the following regions:Biopsy site and contralateral to the biopsy site.


Enrollment: 12
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: [18F]Flutemetamol
All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
Other Names:
  • Flutemetamol
  • AH110690

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092546

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
i3 Statprobe
Investigators
Study Director: Kim A Mansfield, MS GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01092546     History of Changes
Other Study ID Numbers: GE-067-009
Study First Received: March 23, 2010
Last Updated: August 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GE Healthcare:
Amyloid
Normal pressure hydrocephalus (NPH)
Positron Emission Tomography (PET)
Standard uptake value ratios (SUVR)

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on June 18, 2013