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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00185848
Other study ID # BRNCNS0003
Secondary ID 95908BRNCNS0003
Status Completed
Phase Phase 1
First received September 12, 2005
Last updated March 12, 2017
Start date April 2005
Est. completion date June 2013

Study information

Verified date March 2017
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion Criteria:

- Below 18 years of age

Study Design


Intervention

Radiation:
[18F]FHBG
< 7mCi and 2 ug, iv

Locations

Country Name City State
United States University of California Los Angeles Los Angeles California
United States Stanford University School of Medicine Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Sanjiv Sam Gambhir

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint of the study for each patient is acquisition of PET/CT image. Time of scan
Secondary Collection of vital signs, EKG, blood chemistry and CBC data day 1, 2 and 8.
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