18F-AV-1451 PET Imaging in TBI

Phase 1

Withdrawn

• Conditions: Traumatic Brain Injury
• Interventions: Drug: 18F-AV-1451

• Registration Number: NCT02512029
• Lead Sponsor: Avid Radiopharmaceuticals

Brief Summary

This study will evaluate imaging characteristics of 18F-AV-1451 in subjects with subacute traumatic brain injury.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-30
• Study Start: 2015-10
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

TBI Subjects

• Subjects that have consented and are currently enrolled in either Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI), Evaluation, Pathogenesis, and Outcome of Subjects with or Suspected Traumatic Brain Injury Protocol Number: CNS: 10-N-N122, or Evaluation and Diagnosis of Potential Research Subjects with Traumatic Brain Injury (TBI): Protocol Number: 11-N-0084
• History of having sustained a TBI < 6 weeks prior to enrollment
• Can tolerate PET and MRI scan procedures

Control Subjects

• MMSE ≥ 28
• No significant history of cognitive impairment
• No prior history of TBI
• Can tolerate PET and MRI scan procedures

Exclusion Criteria

• Have behavior dysfunction that is likely to interfere with imaging
• Are claustrophobic or otherwise unable to tolerate the imaging procedure
• Have current clinically significant cardiovascular disease, or clinically significant abnormalities on screening ECG
• A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs that are known to cause QT-prolongation
• Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
• Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
• Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the 18F-AV-1451 imaging session
• Have current alcohol dependence or alcohol dependence within the past 1 year
• Are currently participating in another interventional clinical trial
• Have evidence of a penetrating brain injury
• Have participated in contact sports in college or after high school age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TBI Subjects	18F-AV-1451	Subjects with history of recent subacute Traumatic Brain Injury (TBI) will receive a single IV injection, 370 megabecquerel (MBq) \[10 millicurie (mCi)\] of 18F-AV-1451 2 to 6 weeks following injury. They will return for a follow-up injection approximately 6 months following injury.
Control	18F-AV-1451	Cognitively healthy volunteer subjects will receive a single IV injection, 370 megabecquerel (MBq) \[10 millicurie (mCi)\] of 18F-AV-1451.

Primary Outcome Measures

Name	Time	Method
Relationship Between Clinical Presentation and Tau Deposition (MMSE)	75-105 minutes postinjection	The relationship between 18F-AV-1451 uptake and clinical measures using Mini-Mental State Examination (MMSE).
TBI Biomarker Analysis	75-105 minutes postinjection	18F-AV-1451 uptake will be compared in subjects with TBI and controls.
Change in tau deposition over time	6 months	Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake over time.
Relationship Between Clinical Presentation and Tau Deposition (BIS-11)	75-105 minutes postinjection	The relationship between 18F-AV-1451 uptake and clinical measures using Barratt Impulsivity Scale 11 (BIS-11)

Trial Locations

Locations (1)

NIH Clinical Center; 🇺🇸 Bethesda, Maryland, United States