Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury
NCT05337774 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-05-14
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.
Conditions
- Mild Traumatic Brain Injury
Interventions
- 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.
Sponsors & Collaborators
-
Walter Reed National Military Medical Center
collaborator FED -
Life Molecular Imaging SA
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 54 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-06-07
- Primary Completion
- 2022-04-30
- Completion
- 2022-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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