Trial Outcomes & Findings for Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus (NCT NCT01092546)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

12 participants

Primary outcome timeframe

Post flutemetamol Injection

Results posted on

2013-12-13

Participant Flow

Started with 16 subjects and 4 withdrew prior to dosing leaving 12 subjects for study.

Participant milestones

Participant milestones
Measure	Arm 1-Flutemetamol Injection \[18F\]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.
Overall Study STARTED	16
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1-Flutemetamol Injection \[18F\]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.
Overall Study Subjects withdrawn prior to dosing	4

Baseline Characteristics

Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1-Flutemetamol Injection n=12 Participants \[18F\]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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	71 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Post flutemetamol Injection

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm 1-Flutemetamol Injection n=12 Participants \[18F\]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.
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region. Biopsy Site	0.64 Correlation Coefficient of the Site
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region. Composite Region	0.81 Correlation Coefficient of the Site
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region. Contralateral to Biopsy Site	0.69 Correlation Coefficient of the Site

SECONDARY outcome

Timeframe: Post flutemetamol administration

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm 1-Flutemetamol Injection n=12 Participants \[18F\]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.
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region. Biopsy Site	0.60 Correlation Coefficient of the site
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region. Contralateral to Biopsy Site	0.63 Correlation Coefficient of the site
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region. Composite Region	0.76 Correlation Coefficient of the site

Adverse Events

Arm 1-Flutemetamol Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Sherwin, M.D.

GE Healthcare

Phone: 609-514-6820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place