Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

• Sponsor: GE Healthcare (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01092546
• Collaborator: i3 Statprobe (Industry)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 13
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Normal Pressure Hydrocephalus	Drug: [18F]Flutemetamol	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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 Normal Pressure Hydrocephalus (NPH) Subjects.
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region. [Post flutemetamol Injection]

   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 Normal Pressure Hydrocephalus (NPH). The quantitative estimates of brain uptake of [18F]flutemetamol (SUVR) will be made from the analysis of PET images.

Secondary Outcome Measures

1. Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region. [Post flutemetamol administration]

   The level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the following regions: Biopsy site and Contralateral and Composite Regions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	GE Healthcare	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• GE Healthcare
• i3 Statprobe

Investigators

• Study Director: Kim A Mansfield, MS, GE Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT01092546
• Other Study ID Numbers: GE-067-009
• First Posted: Mar 25, 2010
• Last Update Posted: Dec 13, 2013
• Last Verified: Nov 1, 2013

• 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; Flutemetamol

Study Results

Participant Flow

Pre-assignment Detail	Started with 16 subjects and 4 withdrew prior to dosing leaving 12 subjects for study.

Arm/Group Title	Arm 1-Flutemetamol Injection
Arm/Group Description	[18F]Flutemetamol : All subjects received 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.
Period Title: Overall Study
STARTED	16
COMPLETED	12
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Arm 1-Flutemetamol Injection
Arm/Group Description	[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.
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 25%
>=65 years	9 75%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71 (8.1)
Sex: Female, Male (Count of Participants)
Female	5 41.7%
Male	7 58.3%
Region of Enrollment (participants) [Number]
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region.
Description	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 Normal Pressure Hydrocephalus (NPH). The quantitative estimates of brain uptake of [18F]flutemetamol (SUVR) will be made from the analysis of PET images.
Time Frame	Post flutemetamol Injection

Outcome Measure Data

Analysis Population Description

The correlation coefficient listed in the table is between SUVR-CER and the percent area of Amyloid. Stain IHC 4G8 was used as the Standard of Truth. Standard Uptake Value Ratio (SUVR) at the site of the biopsy was based on the cerebullum (CER) as the reference region.

Arm/Group Title	Arm 1-Flutemetamol Injection
Arm/Group Description	[18F]Flutemetamol : All subjects received 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.
Measure Participants	12
Biopsy Site	0.64
Contralateral to Biopsy Site	0.69
Composite Region	0.81

2. Secondary Outcome

Title	Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region.
Description	The level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the following regions: Biopsy site and Contralateral and Composite Regions.
Time Frame	Post flutemetamol administration

Outcome Measure Data

Analysis Population Description

The correlation coefficient listed in the table is between SUVR-Pons and the percent area of Amyloid. Stain IHC 4G8 was used as the Standard of Truth. Standard Uptake Value Ratio (SUVR) at the site of the biopsy was based on the Pons as the reference region.

Arm/Group Title	Arm 1-Flutemetamol Injection
Arm/Group Description	[18F]Flutemetamol : All subjects received 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.
Measure Participants	12
Biopsy Site	0.60
Contralateral to Biopsy Site	0.63
Composite Region	0.76

Adverse Events

Arm/Group Title	Arm 1-Flutemetamol Injection
Arm/Group Description	[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.
All Cause Mortality
	Arm 1-Flutemetamol Injection
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Arm 1-Flutemetamol Injection
	Affected / at Risk (%)	# Events
Total	0/12 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1-Flutemetamol Injection
	Affected / at Risk (%)	# Events
Total	0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.