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Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Primary Purpose

Normal Pressure Hydrocephalus

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

[18F]Flutemetamol

About this trial

This is an interventional diagnostic trial for Normal Pressure Hydrocephalus focused on measuring Amyloid, Normal pressure hydrocephalus (NPH), Positron Emission Tomography (PET), Standard uptake value ratios (SUVR)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

GE Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01092546

First Posted

March 23, 2010

Last Updated

November 20, 2013

Sponsor

GE Healthcare

Collaborators

i3 Statprobe

1. Study Identification

Unique Protocol Identification Number

NCT01092546

Brief Title

Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

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 Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Terminated

Why Stopped

Changed focus of the program

Study Start Date

March 2010 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GE Healthcare

Collaborators

i3 Statprobe

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Normal Pressure Hydrocephalus

Keywords

Amyloid, Normal pressure hydrocephalus (NPH), Positron Emission Tomography (PET), Standard uptake value ratios (SUVR)

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

[18F]Flutemetamol

Other Intervention Name(s)

Flutemetamol, AH110690

Intervention Description

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.

Primary Outcome Measure Information:

Title

Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region.

Description

Time Frame

Post flutemetamol Injection

Secondary Outcome Measure Information:

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kim A Mansfield, MS

Organizational Affiliation

GE Healthcare

Official's Role

Study Director

Facility Information:

Facility Name

GE Healthcare

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

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