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

This study is currently recruiting participants.
Verified May 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00185848
First received: September 12, 2005
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Glioma
 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:

U.S. FDA Resources

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.


Estimated Enrollment: 10
Study Start Date: April 2005
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 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.

  Eligibility

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.

Criteria

Inclusion Criteria:

- Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion Criteria:

- Below 18 years of age

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

Contacts
Contact: Shahriar Yaghoubi (650) 725-6070 syaghoub@stanford.edu

Locations
United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Shahriar Yaghoubi     650-725-6070     syaghoub@stanford.edu    
Sub-Investigator: Shahriar Yaghoubi            
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Shahriar Shah Yaghoubi, Ph.D     650-725-6070     syaghoub@stanford.edu    
Contact: Lindee Burton     (650) 725-4712     lburton@stanford.edu    
Principal Investigator: Sanjiv Sam Gambhir M.D., Ph.D.            
Sub-Investigator: Michael L Goris            
Sub-Investigator: Dr Andrew Quon            
Sub-Investigator: Dr Lawrence Recht            
Sub-Investigator: Shahriar Shah Yaghoubi            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sanjiv Sam Gambhir M.D., Ph.D. Stanford University
  More Information

Publications:

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00185848     History of Changes
Other Study ID Numbers: BRNCNS0003, 95908, BRNCNS0003
Study First Received: September 12, 2005
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Brain Neoplasms
Neoplasms
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 23, 2013