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| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | September 29, 2009 | ||||
| Start Date ICMJE | April 2005 | ||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00185848 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Assessing the Suitability of an Imaging Probe for Use in Clinical Gene Therapy Trials in Cancer and Rheumatoid Arthritis | ||||
| Official Title ICMJE | Imaging the Biodistribution of the Positron Emission Tomography Reporter Probe, [18F]FHBG, in Humans. | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | Yaghoubi S, Barrio JR, Dahlbom M, Iyer M, Namavari M, Satyamurthy N, Goldman R, Herschman HR, Phelps ME, Gambhir SS. Human pharmacokinetic and dosimetry studies of [(18)F]FHBG: a reporter probe for imaging herpes simplex virus type-1 thymidine kinase reporter gene expression. J Nucl Med. 2001 Aug;42(8):1225-34. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 10 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:- Clinical diagnosis of brain tumor or rheumatoid arthritis Exclusion Criteria:- Below 18 years of age |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00185848 | ||||
| Responsible Party | Sanjiv Sam Gambhir M.D., Ph.D., Principal Investigator, Stanford University School of Medicine | ||||
| Study ID Numbers ICMJE | BRNCNS0003, 95908, BRNCNS0003, NCT00185848 | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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