Assessing the Suitability of an Imaging Probe for Use in Clinical Cell and Gene Therapy Trials in Cancer and Rheumatoid Arthritis
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.
Central Nervous System Neoplasms
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Imaging the Biodistribution of the Positron Emission Tomography Reporter Probe, [18F]FHBG, in Humans.|
- 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 ]
- 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.
|Study Start Date:||April 2005|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov 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|
|Principal Investigator:||Sanjiv Sam Gambhir M.D., Ph.D.||Stanford University|