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Summary

for people ages 18–65 (full criteria)
at San Francisco, California
study started
estimated completion:

Description

Summary

This is a Phase 1 study is to visualize biodistribution of a PET tracer called [18F]F-AraG (VisAcT) in cancer patients expected to undergo immunotherapy.

Official Title

Study of the Kinetics, Dosimetry and Safety of [18F]F-AraG (VisAcT), a Positron Emission Tomography Tracer for Imaging the Activation of the Immune System in Cancer Patients Expected to Undergo Immunotherapy

Details

This is an exploratory Phase 1, prospective study assessing the biodistribution and radiation dosimetry of the Positron Emission Tomography [18F]FAraG (VisAcT) in cancer patients selected for immunotherapy. Each patient may have up to two [ 18F]FAraG PET imaging sessions, a baseline image and a post start of immunotherapy image. For each imaging session, patients will receive a single injection of [ 18F]FAraG and undergo up to four whole-body PET scans in the same day. Blood samples may be collected at up to 9 time points post-injection to analyze whole-blood/plasma time activity of [18F]FAraG. Following each imaging session, we will also assess safety in each subject. Blood pressure, heart rate, pulse oximetry, temperature, and respiratory count measurements as well as an electrocardiogram (ECG) recording will be taken prior to imaging, and after whole-body PET scans are completed.

Keywords

Cancer

Eligibility

You can join if…

Open to people ages 18–65

  • Cancer patients with identified tumor mass
  • Cancer patients expected to undergo immunotherapy

You CAN'T join if...

  • Under the age of 18
  • Pregnant women
  • Women who are breastfeeding
  • Individuals with known or suspected substance abuse
  • Individuals unable or unwilling to comply with the study procedures
  • Patients currently receiving immunotherapy treatment

Location

  • UCSF Imaging Center at China Basin accepting new patients
    San Francisco, California, 94107, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CellSight Technologies, Inc.
ID
NCT03142204
Phase
Phase 1
Lead Scientist
Henry VanBrocklin
Study Type
Interventional
Last Updated
July 18, 2017
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