18F-AV-1451 PET Imaging in TBI

Avid Pharmaceuticals

Status and phase: Withdrawn; Phase 1

Conditions: Traumatic Brain Injury

Treatments: Drug: 18F-AV-1451

Study type: Interventional

Funder types: Industry

Identifiers

NCT02512029

18F-AV-1451-A12

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

TBI Subjects

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

TBI Subjects

Experimental group

Description:

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.

Treatment:

Drug: 18F-AV-1451

Control

Experimental group

Description:

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

Treatment:

Drug: 18F-AV-1451