Trials / Completed
CompletedNCT05270083
Neuraceq™ PET for Detection of Brain Changes in Young Athletes Post-concussion
Role of NeuraceqTM (Florbetaben F18 Injection) PET in Young Athletes With and Without Persistent Cognitive Complaints Following Multiple Concussions: A Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Dartmouth-Hitchcock Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to learn if Neuraceq™ (Florbetaben F 18 Injection) PET can detect changes in the brains of young athletes who sustained one or more concussions with or without persistent cognitive complaints at least 5 years after injury.
Detailed description
Former college athletes who sustained at least one previous concussion will undergo computerized neurocognitive testing and a structured questionnaire of present symptoms. \[F-18\] Florbetaben PET images will be acquired dynamically, with data binned in 20 time frames of 1 min each (early phase), followed by 4 frames of 5 min each (late phase), with image frames summed within each phase after linearly coregistering to subjects' mean images, then elastically transformed to template space of a florbetaben scan used in standardized volume of interest quantification, and intensity normalized to mean voxel value within each phase.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | NeuraCeq PET imaging with intravenous (IV) dose of 300MBq of Neuraceq™ ([F-18]Florbetaben) | Participants will receive an intravenous (IV) dose of 300 MBq of Neuraceq™ in a volume of 10 mL or less. A 30 minute duration PET image will be acquired starting immediately after Neuraceq™ injection. A second 20-minute duration PET image will be acquired starting 90 minutes after Neuraceq™ injection. |
Timeline
- Start date
- 2017-07-13
- Primary completion
- 2019-10-10
- Completion
- 2019-10-10
- First posted
- 2022-03-08
- Last updated
- 2024-02-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05270083. Inclusion in this directory is not an endorsement.