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[18F]FAraG (VisAcT) PET Imaging for Analysis of Biodistribution in Cancer Patients Expected to Undergo Immunotherapy

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ClinicalTrials.gov Identifier: NCT03142204
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
UCSF Imaging Center at China Basin
Information provided by (Responsible Party):
CellSight Technologies, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cancer Drug: [18F]F-AraG Phase 1

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

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Arms and Interventions
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Intervention Details:
  • Drug: [18F]F-AraG
    Single dose IV injection of [18F]F-AraG for each imaging day.

Outcome Measures
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Primary Outcome Measures :
  1. Visualize biodistribution of the PET tracer [18F]F-AraG pre-immunotherapy [ Time Frame: Up to 6 weeks before immunotherapy is administered ]
    Whole-body [18F]F-AraG PET scans will be performed at up to 4 different consecutive time points the day of the intravenous injection of the PET tracer. Up to four whole-body images will be obtained that will reveal biodistribution of [18F]F-AraG at up to 4 different consecutive time points on the day of the intravenous injection.

  2. Visualize biodistribution of the PET tracer [18F]F-AraG post start of immunotherapy [ Time Frame: Up to 12 weeks after start of immunotherapy ]
    Whole-body [18F]F-AraG PET scans will be performed at up to 4 different consecutive time points the day of the intravenous injection of the PET tracer. Up to four whole-body images will be obtained that will reveal biodistribution of [18F]F-AraG at up to 4 different consecutive time points on the day of the intravenous injection.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03142204


Contacts
Contact: Henry VanBrocklin, Ph.D. 415-353-4569 henry.vanbrocklin@radiology.ucsf.edu
Contact: Samuel Quezada, MBA 650-799-1589 squezada@cellsighttech.com

Locations
United States, California
UCSF Imaging Center at China Basin Recruiting
San Francisco, California, United States, 94107
Contact: Kenneth Gao    415-353-9437    kenneth.gao@ucsf.edu   
Sponsors and Collaborators
CellSight Technologies, Inc.
UCSF Imaging Center at China Basin
Investigators
Principal Investigator: Henry VanBrocklin, Ph.D. UCSF Imaging Center China Basin
More Information
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Responsible Party: CellSight Technologies, Inc.
ClinicalTrials.gov Identifier: NCT03142204     History of Changes
Other Study ID Numbers: 14-14488
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No