18F-AV-1451 PET Imaging in TBI

Traumatic Brain Injury Clinical Trial

Official title:

18F-AV-1451 PET Imaging in Subjects With Subacute Traumatic Brain Injury

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02512029
• Other study ID #: 18F-AV-1451-A12
• Status: Withdrawn
• Phase: Phase 1
• First received: July 28, 2015
• Last updated: February 4, 2016
• Start date: October 2015
• Est. completion date: April 2017

Study information

• Verified date: February 2016
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Drug:
• 18F-AV-1451

Locations

Country	Name	City	State
United States	NIH Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TBI Biomarker Analysis	18F-AV-1451 uptake will be compared in subjects with TBI and controls.	75-105 minutes postinjection	No
Primary	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	No
Primary	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	No
Primary	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	No