18F-AV-1451 PET Imaging in TBI

NCT02512029 | Withdrawn Phase 1

• 1 other identifier: 18F-AV-1451-A12
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (4)

• TBI Biomarker Analysis

  18F-AV-1451 uptake will be compared in subjects with TBI and controls.

  75-105 minutes postinjection

• Relationship Between Clinical Presentation and Tau Deposition (MMSE)

  The relationship between 18F-AV-1451 uptake and clinical measures using Mini-Mental State Examination (MMSE).

  75-105 minutes postinjection

• Change in tau deposition over time

  Assess the rate of change of tau deposition as measured by 18F-AV-1451 uptake over time.

  6 months

• Relationship Between Clinical Presentation and Tau Deposition (BIS-11)

  The relationship between 18F-AV-1451 uptake and clinical measures using Barratt Impulsivity Scale 11 (BIS-11)

  75-105 minutes postinjection

Study Arms (2)

TBI Subjects

EXPERIMENTAL

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.

Drug: 18F-AV-1451

Control

EXPERIMENTAL

Cognitively healthy volunteer subjects will receive a single IV injection, 370 megabecquerel (MBq) \[10 millicurie (mCi)\] of 18F-AV-1451.

Drug: 18F-AV-1451

Interventions

18F-AV-1451 DRUG

Also known as: [F-18]T807

Control; TBI Subjects

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (1)

NIH Clinical Center

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: July 30, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: February 5, 2016

Record last verified: 2016-02

Locations

US (1)