[18F]FAraG PET Imaging for Analysis of Biodistribution in Cancer Patients Expected to Undergo Immunotherapy and/or Radiation Therapy
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 Who Have Received or Are Expected to Receive Immunotherapy and/or Radiation Therapy
1 other identifier
interventional
30
1 country
1
Brief 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 and/or radiation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 cancer
Started May 2017
Longer than P75 for phase_1 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2017
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedDecember 5, 2022
December 1, 2022
7 years
May 1, 2017
December 1, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Visualize biodistribution of the PET tracer [18F]F-AraG pre-immunotherapy
Whole-body \[18F\]F-AraG PET scan will be performed after intravenous injection of the PET tracer.consecutive time points the day of the intravenous injection of the PET tracer.
Up to 6 weeks before immunotherapy is administered
Visualize biodistribution of the PET tracer [18F]F-AraG post start of immunotherapy
Whole-body \[18F\]F-AraG PET scan will be performed after intravenous injection of the PET tracer.
Up to 12 weeks after start of immunotherapy
Interventions
Single dose IV injection of \[18F\]F-AraG for each imaging day.
Eligibility Criteria
You may qualify if:
- Cancer patients with identified tumor mass
- Cancer patients expected to undergo immunotherapy and/or radiation therapy
You may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CellSight Technologies, Inc.lead
- UCSF Imaging Center at China Basincollaborator
Study Sites (1)
UCSF Imaging Center at China Basin
San Francisco, California, 94107, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Robert R Flavell, M.D., Ph.D.
UCSF Department of Radiology & Biomedical Imaging
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2017
First Posted
May 5, 2017
Study Start
May 1, 2017
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
December 5, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share