Assessing the Suitability of an Imaging Probe for Use in Clinical Cell and Gene Therapy Trials in Cancer and Rheumatoid Arthritis

Glioma Clinical Trial

Official title:

Imaging the Biodistribution of the Positron Emission Tomography Reporter Probe, [18F]FHBG, in Humans.

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
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Brain Cancer
• Brain Neoplasms
• Central Nervous System Neoplasms
• Glioma
• Nervous System Neoplasms

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.