Clinical Evaluation of 18F-AV-1451

Study ID
STU 092015-003

Cancer Related
No

Healthy Volunteers
Yes

Study Sites

  • Advanced Imaging Research Center (AIRC)
  • Clements University Hospital
  • UT Southwestern Ambulatory Services

Contact
Bela Bhatia
972/567-9789
bela.bhatia@utdallas.edu

Principal Investigator
Denise Park

Official Title

Clinical Evaluation of 18F-AV-1451

Brief Overview

This study is designed to expand the database of 18F-AV-1451 safety and tau binding as measured by PET imaging and to provide standardized conditions for 18F-AV-1451 use, data collection and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.

Eligibility

Subjects should meet inclusion and exclusion criteria for the companion protocol in addition to the criteria below.
Inclusion Criteria:
- Subjects who have a historical volumetric MRI as part of the companion study
Exclusion Criteria:
- Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- Have a screening ECG with QTc > 450 msec if male or QTc > 470 msec if female
- Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the setting of intraventricular conduction block may be enrolled with sponsor approval
- Have a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence unless approved by the sponsor
- Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- Have a history of relevant severe drug allergy or hypersensitivity
- Are patients who have received an investigational medication under an FDA IND protocol within 30 days prior to the planned imaging session for this study
- Are patients with current clinically significant unstable medical comorbidities
- Are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study