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

This study has been completed.
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University Identifier:
First received: September 12, 2005
Last updated: November 16, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Brain Cancer
Arthritis, Rheumatoid
Central Nervous System Neoplasms
Radiation: [18F]FHBG
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging the Biodistribution of the Positron Emission Tomography Reporter Probe, [18F]FHBG, in Humans.

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • The primary endpoint of the study for each patient is acquisition of PET/CT image. [ Time Frame: Time of scan ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Collection of vital signs, EKG, blood chemistry and CBC data [ Time Frame: day 1, 2 and 8. ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained
Patients with intact or surgically removed gliomas.Patients with Rheumatoid Arthritis.

Enrollment: 10
Study Start Date: April 2005
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: [18F]FHBG
    < 7mCi and 2 ug, iv
    Other Name: 18F-FHBG
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Rheumatoid Arthritis.Patients with intact or surgically removed gliomas.

Inclusion Criteria:

- Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion Criteria:

- Below 18 years of age

  Contacts and Locations
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Please refer to this study by its identifier: NCT00185848

United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Sanjiv Sam Gambhir
Principal Investigator: Sanjiv Sam Gambhir M.D., Ph.D. Stanford University
  More Information

Responsible Party: Sanjiv Sam Gambhir, Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research, Stanford University Identifier: NCT00185848     History of Changes
Other Study ID Numbers: BRNCNS0003  95908  BRNCNS0003 
Study First Received: September 12, 2005
Last Updated: November 16, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Central Nervous System Neoplasms
Nervous System Neoplasms
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Neoplasms by Site
Nervous System Diseases
Rheumatic Diseases processed this record on May 04, 2016