Normal Pressure Hydrocephalus
Conditions
Keywords
Amyloid, Normal pressure hydrocephalus (NPH), Positron Emission Tomography (PET), Standard uptake value ratios (SUVR)
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.
Interventions
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.
Sponsors
i3 Statprobe
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Started with 16 subjects and 4 withdrew prior to dosing leaving 12 subjects for study.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1-Flutemetamol Injection \[18F\]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. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subjects withdrawn prior to dosing | 4 |
Baseline characteristics
| Characteristic | Arm 1-Flutemetamol Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 71 years STANDARD_DEVIATION 8.1 |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the Cerebellum (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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1-Flutemetamol Injection | 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 |
| Arm 1-Flutemetamol Injection | 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 |
| Arm 1-Flutemetamol Injection | 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 |
Secondary
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy 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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1-Flutemetamol Injection | 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 |
| Arm 1-Flutemetamol Injection | 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 |
| Arm 1-Flutemetamol Injection | 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 |