Assessing the Suitability of an Imaging Probe for Use in Clinical Cell and Gene Therapy Trials in Cancer and Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT00185848 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : March 14, 2017
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Sponsor:
Sanjiv Sam Gambhir
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University
Tracking Information | ||||
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First Submitted Date ICMJE | September 12, 2005 | |||
First Posted Date ICMJE | September 16, 2005 | |||
Last Update Posted Date | March 14, 2017 | |||
Study Start Date ICMJE | April 2005 | |||
Actual Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
The primary endpoint of the study for each patient is acquisition of PET/CT image. [ Time Frame: Time of scan ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Collection of vital signs, EKG, blood chemistry and CBC data [ Time Frame: day 1, 2 and 8. ] | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Assessing the Suitability of an Imaging Probe for Use in Clinical Cell and 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 cell or gene therapy trials. In this phase 1 study we will assess the safety and biodistribution of [18F]FHBG in patients. | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Radiation: [18F]FHBG
< 7mCi and 2 ug, iv
Other Name: 18F-FHBG
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Study Arms ICMJE | Experimental: [18F]FHBG arm
Intervention: Radiation: [18F]FHBG
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
10 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | June 2013 | |||
Actual Primary Completion Date | June 2013 (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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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00185848 | |||
Other Study ID Numbers ICMJE | BRNCNS0003 95908 ( Other Identifier: Stanford University Alternate IRB Approval Number ) BRNCNS0003 ( Other Identifier: Stanford University ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Sanjiv Sam Gambhir, Stanford University | |||
Study Sponsor ICMJE | Sanjiv Sam Gambhir | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Stanford University | |||
Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |