Expired Study
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Bethesda, Maryland 20892


Purpose:

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


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


NCT ID:

NCT02512029


Primary Contact:

Study Chair
Chief Medical Officer
Avid Radiopharmaceuticals, Inc.


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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