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

Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323893
• Other study ID #: 261201300063
• Status: Completed
• Phase: Phase 1
• Start date: February 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2018
• Source: CellSight Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• [18F]F-AraG

Locations

Country	Name	City	State
United States	UCSF Imaging Center at China Basin	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
CellSight Technologies, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Namavari M, Chang YF, Kusler B, Yaghoubi S, Mitchell BS, Gambhir SS. Synthesis of 2'-deoxy-2'-[18F]fluoro-9-ß-D-arabinofuranosylguanine: a novel agent for imaging T-cell activation with PET. Mol Imaging Biol. 2011 Oct;13(5):812-8. doi: 10.1007/s11307-010- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualize biodistribution of the PET tracer [18F]F-AraG	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.	1 day
Primary	Analyze human dosimetry of [18F]F-AraG	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.	1 day
Primary	Assess acute safety of intravenously injected trace dose of [18F]F-AraG	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.	8 days

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