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Completed

NCT Number: NCT02323893

Study of Kinetics, Dosimetry & Safety of [18F]F-AraG, a Positron Emission Tomography Imaging Tracer in Healthy Humans

The goal of this study is to visualize biodistribution of a PET tracer called [18F]F-AraG through time in healthy human volunteers.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UCSF Imaging Center at China Basin

San Francisco, California, 94107, United States

About this study

A positron emission tomography (PET) imaging tracer will be intravenously injected into healthy human volunteers who provide informed consent. Following injection of this tracer each volunteer will have four whole-body PET scans inside a PET scanner to obtain images of tracer biodistribution at four different time points. This will allow studying the kinetics of the tracer as well analysis of tracer dosimetry. Safety of the tracer will also be analyzed in each volunteer.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy human subjects without history of chronic disease or at present an acute disease will be included.
  • Ability to abide by the study conditions is also a requirement for inclusion.

Exclusion criteria

  • Individuals under the age of 18 years and pregnant women will be excluded from the [18F]F-AraG imaging studies.
  • Women who are breast-feeding will be excluded from the study.
  • Individuals unable to provide informed consent will be excluded.

Treatment and study plan

[18F]F-AraG

Drug

Primary outcomes

  1. Visualize biodistribution of the PET tracer [18F]F-AraG

    Time frame: 1 day

    Whole-body [18F]F-AraG PET scans will be performed at 4 different time points following intravenous injection of the PET tracer. Four whole-body images will be obtained that will reveal biodistribution of [18F]F-AraG at 4 different consecutive time points after intravenous injection.

  2. Analyze human dosimetry of [18F]F-AraG

    Time frame: 1 day

    Time-Activity curves will be graphed by measuring activity in various organs at the 4 time points after tracer injection. From these time activity curves absorbed radiation will be calculated.

  3. Assess acute safety of intravenously injected trace dose of [18F]F-AraG

    Time frame: 8 days

    Blood and urine samples may be collected at baseline and at 1 and 8 days after injection of [18F]F-AraG to perform metabolic panel, CBC and urine analysis. Vital signs and EKG will be measured and recorded at baseline, within 3 hours after tracer injection and at 1 and 8 days after tracer injection.

Sponsors and collaborators

Lead sponsor

CellSight Technologies, Inc.

Industry

Registry information

Official study title

Study of the Kinetics, Dosimetry and Safety of [18F]F-AraG, a Positron Emission Tomography Tracer for Imaging the Activation of the Immune System in Healthy Humans

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 24, 2014
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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