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Trial record 6 of 92 for:    avid

Augmenting 18F-AV-1451 Dosimetry Estimates

This study has been completed.
Information provided by (Responsible Party):
Avid Radiopharmaceuticals Identifier:
First received: January 8, 2015
Last updated: January 21, 2016
Last verified: January 2016
This study will obtain data from urine in subjects administered 18F-AV-1451 in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates.

Condition Intervention Phase
Alzheimer's Disease
Drug: 18F-AV-1451
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Multicenter Study to Obtain Data to Assist in Radiation Dosimetry Calculations From Subjects Enrolled in Human Studies Employing 18F-AV-1451

Resource links provided by NLM:

Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Urine Analysis - Total integrated radioactivity excreted in urine [ Time Frame: 0-360 min post injection ]
    Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations.

Enrollment: 6
Study Start Date: January 2015
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Urine Analysis
Urine will be collected from subjects administered 18F-AV-1451 in an Avid-sponsored study to determine the amount of radioactivity excreted in urine.
Drug: 18F-AV-1451
370 megabecquerel (MBq) (10 millicurie [mCi]) administered in a separate Avid-sponsored study. No drug will be administered in this study.
Other Name: [F-18]T807


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects who passed screening in an Avid-sponsored study in which 18F-AV-1451 will be administered

Exclusion Criteria:

  • Subjects who have withdrawn informed consent
  • Investigator or sponsor believes it is in the best interest of the subject to be removed from the trials
  Contacts and Locations
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Please refer to this study by its identifier: NCT02336360

United States, Connecticut
Molecular NeuroImaging
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Avid Radiopharmaceuticals
  More Information

Responsible Party: Avid Radiopharmaceuticals Identifier: NCT02336360     History of Changes
Other Study ID Numbers: 18F-AV-1451-A15 
Study First Received: January 8, 2015
Last Updated: January 21, 2016

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on February 27, 2017