Normal Pressure HydrocephalusPhase 3NCT01092546
Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
A Phase 3 study testing [18F]Flutemetamol in people with Normal Pressure Hydrocephalus, run by GE Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- [18F]Flutemetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Apr 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- [18F]Flutemetamol
- Keywords
- Amyloid, Normal pressure hydrocephalus (NPH), Positron Emission Tomography (PET), Standard uptake value ratios (SUVR)
- Medical subject headings
- Hydrocephalus, Normal Pressure, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FlutemetamolDrug
Also called Flutemetamol, AH110690
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: [18F]Flutemetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post flutemetamol Injection
Secondary outcomes (1)
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.
Measured: Post flutemetamol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Changed focus of the program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- i3 Statprobe
- Responsible party
- Sponsor
- Investigators
- Kim A Mansfield, MS, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092546
- Sponsor's protocol ID
- GE-067-009
- Status last verified
- Nov 2013
- First submitted
- 23 Mar 2010
- Last updated
- 13 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01092546
- Acronym / sponsor ID
- GE-067-009
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- Amyloid, Normal pressure hydrocephalus (NPH), Positron Emission Tomography (PET), Standard uptake value ratios (SUVR)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changed focus of the program
- Enrolment
- 12 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- i3 Statprobe
- Study start
- Mar 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Posted 19 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: [18F]Flutemetamol |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FlutemetamolAlso: Flutemetamol, AH110690All 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. | Drug | Arm 1 |
Primary outcome
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region.
Time frame: 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.
1 secondary outcome
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Pons" as the Reference Region.
Time frame: Post flutemetamol administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim A Mansfield, MS study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [18F]Flutemetamol in people with Normal Pressure Hydrocephalus, run by GE Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the "Cerebellum" (CER) as the Reference Region. (time frame: Post flutemetamol Injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013.