NCT05337774

Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Life Molecular Imaging SA · Industry
• Sex: Male
• Age: 25 Years – 54 Years
• Healthy volunteers: Accepted

Summary

The main objective of this interdisciplinary study is to develop an understanding of the molecular imaging features of blast-related mild traumatic brain injury (mTBI) in military personnel, while helping to establish assessment tools that may be of use in diagnosis, determining prognosis, and in future therapeutic clinical trials. Additionally, the objective is to evaluate feasibility of \[18F\]PI-2620 in the assessment TBI.

Detailed description

The main objective of this interdisciplinary study is to develop an understanding of the molecular imaging features of blast-related mild traumatic brain injury (mTBI) in military personnel, while helping to establish assessment tools that may be of use in diagnosis, determining prognosis, and in future therapeutic clinical trials. Additionally, the objective is to evaluate feasibility of \[18F\]PI-2620 in the assessment TBI. This particular tracer has been shown to be effective in localizing tau deposition. \[18F\]PI-2620 has not yet received FDA approval for routine clinical use and for the purpose of this study is considered an Investigational New Drug (IND) by the FDA.

Conditions

• Mild Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	[18F]PI-2620	The participant will be injected with 5 mCi (185 MBq) \[18F\]PI-2620 via a short line which will be placed in an intravenous line in an antecubital vein. Subjects will be placed in the scanner after injection and dynamic scans will be acquired for 0 to 60 minutes post injection.

Timeline

• Start date: 2021-06-07
• Primary completion: 2022-04-30
• Completion: 2022-04-30
• First posted: 2022-04-20
• Last updated: 2024-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study