CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7 enrolled
Drug / intervention
[18F] Flutemetamoldrug
Likely dose
[18F] Flutemetamol 10µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01053312
NCT01053312Phase 3Completed
CompareCT.gov

A Principal, Open-Label, Single Center Study to Validate the Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Subjects Previously Biopsied

GE Healthcare·interventional·Posted Jan 21, 2010·Updated Jun 11, 2012

In Brief

A Phase 3 clinical trial evaluating [18F] Flutemetamol for Normal Pressure Hydrocephalus. Completed, enrolled 7 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNormal Pressure Hydrocephalus
CountriesUnited States
Collaboratorsi3 Statprobe

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2010
Enrollment StartDec 1, 2009
Primary CompletionJul 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.4 years ago

Interventions

[18F] Flutemetamoldrug

All subjects will receive an intravenous (IV) dose of \[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels (MBq).