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Trial record 6 of 92 for:    avid

Augmenting 18F-AV-1451 Dosimetry Estimates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT02336360
First received: January 8, 2015
Last updated: January 21, 2016
Last verified: January 2016
  Purpose
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

  Eligibility

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

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  • Subjects who have withdrawn informed consent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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02336360

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

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov 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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 27, 2017