Back to resultsAssessing the Suitability of an Imaging Probe for Use in Clinical Cell and Gene Therapy Trials in Cancer and Rheumatoid Arthritis
Primary Purpose
Brain Cancer, Arthritis, Rheumatoid, Central Nervous System Neoplasms
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]FHBG
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Cancer
Eligibility Criteria
Inclusion Criteria: - Clinical diagnosis of brain tumor or rheumatoid arthritis Exclusion Criteria: - Below 18 years of age
Sites / Locations
- University of California Los Angeles
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F]FHBG arm
Arm Description
Outcomes
Primary Outcome Measures
The primary endpoint of the study for each patient is acquisition of PET/CT image.
Secondary Outcome Measures
Collection of vital signs, EKG, blood chemistry and CBC data
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00185848
Brief Title
Assessing the Suitability of an Imaging Probe for Use in Clinical Cell and Gene Therapy Trials in Cancer and Rheumatoid Arthritis
Official Title
Imaging the Biodistribution of the Positron Emission Tomography Reporter Probe, [18F]FHBG, in Humans.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sanjiv Sam Gambhir
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer, Arthritis, Rheumatoid, Central Nervous System Neoplasms, Glioma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[18F]FHBG arm
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
[18F]FHBG
Other Intervention Name(s)
18F-FHBG
Intervention Description
< 7mCi and 2 ug, iv
Primary Outcome Measure Information:
Title
The primary endpoint of the study for each patient is acquisition of PET/CT image.
Time Frame
Time of scan
Secondary Outcome Measure Information:
Title
Collection of vital signs, EKG, blood chemistry and CBC data
Time Frame
day 1, 2 and 8.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of brain tumor or rheumatoid arthritis
Exclusion Criteria:
- Below 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjiv Sam Gambhir M.D., Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11483684
Citation
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.
Results Reference
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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
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