Assessing the Suitability of an Imaging Probe for Use in Clinical Cell and Gene Therapy Trials in Cancer and Rheumatoid Arthritis

March 12, 2017 updated by: Sanjiv Sam Gambhir

Imaging the Biodistribution of the Positron Emission Tomography Reporter Probe, [18F]FHBG, in Humans.

The purpose of this study is to determine whether [18F]FHBG is suitable for use as an imaging probe in cancer or rheumatoid arthritis patients enrolled in cell or gene therapy trials. In this phase 1 study we will assess the safety and biodistribution of [18F]FHBG in patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The success of cell and gene therapy depends on specific targeting of the therapeutic gene or cell that is administered to the patient. Our goal is to develop an imaging method to non-invasively monitor the location of the therapeutic gene or cell. Imaging should help in the design of better protocols and potentially reduce side-effects of cell and gene therapy.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion Criteria:

- Below 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F]FHBG arm
Radiation: [18F]FHBG
< 7mCi and 2 ug, iv
Other Names:
  • 18F-FHBG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint of the study for each patient is acquisition of PET/CT image.
Time Frame: Time of scan
Time of scan

Secondary Outcome Measures

Outcome Measure
Time Frame
Collection of vital signs, EKG, blood chemistry and CBC data
Time Frame: day 1, 2 and 8.
day 1, 2 and 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanjiv Sam Gambhir

Investigators

  • Principal Investigator: Sanjiv Sam Gambhir M.D., Ph.D., Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

March 14, 2017

Last Update Submitted That Met QC Criteria

March 12, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRNCNS0003 (Other Identifier: Stanford University)
  • 95908 (Other Identifier: Stanford University Alternate IRB Approval Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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