18F-AV-1451 PET Imaging in TBI

NCT ID: NCT02512029

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-04-30

Brief Summary

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

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

TBI Subjects

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.

Group Type: EXPERIMENTAL

18F-AV-1451

Intervention Type: DRUG

Control

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

Group Type: EXPERIMENTAL

18F-AV-1451

Intervention Type: DRUG

Interventions

18F-AV-1451

Intervention Type: DRUG

Other Intervention Names

[F-18]T807

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_CHAIR

Avid Radiopharmaceuticals, Inc.

Locations

NIH Clinical Center

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

18F-AV-1451-A12

Identifier Type: -

Identifier Source: org_study_id