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

C

CellSight Technologies

Status and phase

Completed
Phase 1

Conditions

Cancer

Treatments

Drug: [18F]F-AraG

Study type

Interventional

Funder types

Industry

Identifiers

NCT02323893
261201300063

Details and patient eligibility

About

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

Full description

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

18F-FAraG
Experimental group
Description:
A single dose intravenous injection of 18F-FAraG followed by PET scanning.
Treatment:
Drug: [18F]F-AraG

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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