Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01053312 · ClinicalTrials.gov registry record · Phase 3
PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
A Phase 3 study, sponsored by GE Healthcare.
- Completed
- Registry status
- Phase 3
- Development phase
- 7
- Enrollment target
NCT01053312: Completed Phase 3 study, sponsored by GE Healthcare.
NCT01053312 is a Phase 3 study that has completed, run by GE Healthcare. The registered enrollment target is 7 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01053312, a Phase 3 study, has completed, sponsored by GE Healthcare.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 7 participants
- Enrollment target
Study Summary
This study will determine 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 previously obtained during shunt placement in patients who have normal pressure hydrocephalus (NPH).
Primary Outcome
Radiotracers have enabled the in-vivo imaging of amyloid-beta plaques in the brain, one of the histopathologic hallmarks of Alzheimer's disease (AD). Standardized uptake value ratio SUVR)is the quantitive measure of specific tracer uptake, normalized for the non-specific mean uptake in a reference region. SUVR is calculated as SUV\_voi/SUV\_ref with SUV being the integrated activity over a given time period for the volume of interest (SUV\_voi) or reference region (SUV\_ref). VOI means volume of
Interventions
- DRUG [18F] Flutemetamol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-08 |
| Phase | Phase 3 |
What the finished NCT01053312 record still lists
NCT01053312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which [18F] Flutemetamol is the first listed.
NCT01053312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01053312 about?
NCT01053312 is a clinical study titled "PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus". This study will determine 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 previously obtained during shunt placement in patients who have normal pressure hydrocep...
What is the current status of trial NCT01053312?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 7 participants. The study started on 2009-12. Estimated completion is 2010-08.
What interventions are being tested in trial NCT01053312?
The interventions under investigation include: [18F] Flutemetamol (DRUG).
Who is sponsoring clinical trial NCT01053312?
This trial is sponsored by GE Healthcare, which has 99 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01053312's enrollment target sits among peer trials
7 1995th of 2000 higher than 6 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia