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Assessing the Suitability of an Imaging Probe for Use in Clinical Gene Therapy Trials in Cancer and Rheumatoid Arthritis
This study is currently recruiting participants.
Verified by Stanford University, December 2008
Sponsored by: Stanford University
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00185848
  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 gene therapy trials. In this phase 1 study we will assess the safety and biodistribution of [18F]FHBG in patients.


Condition
Central Nervous System Neoplasms
Brain Cancer
Glioma
Arthritis, Rheumatoid

MedlinePlus related topics: Brain Cancer Cancer Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Imaging the Biodistribution of the Positron Emission Tomography Reporter Probe, [18F]FHBG, in Humans.

Further study details as provided by Stanford University:

Estimated Enrollment: 10
Study Start Date: April 2005
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Shahriar Shah Yaghoubi     650-736-9822     syaghoub@stanford.edu    
Contact: Lindee Burton     (650) 721-2024     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:
Study ID Numbers: BRNCNS0003, 95908, BRNCNS0003, NCT00185848
Study First Received: September 12, 2005
Last Updated: December 2, 2008
ClinicalTrials.gov Identifier: NCT00185848  
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Study placed in the following topic categories:
Autoimmune Diseases
Joint Diseases
Arthritis, Rheumatoid
Central Nervous System Diseases
Central Nervous System Neoplasms
Rheumatic Diseases
Brain Diseases
Brain Neoplasms
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Glioma
Nervous System Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009