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

Phase 1

Completed

• Conditions: Arthritis, Rheumatoid; Glioma; Brain Cancer; Central Nervous System Neoplasms
• Interventions: Radiation: [18F]FHBG

• Registration Number: NCT00185848
• Lead Sponsor: Sanjiv Sam Gambhir

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 Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-12
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion Criteria

• Below 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]FHBG arm	[18F]FHBG	-

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study for each patient is acquisition of PET/CT image.	Time of scan

Secondary Outcome Measures

Name	Time	Method
Collection of vital signs, EKG, blood chemistry and CBC data	day 1, 2 and 8.

Trial Locations

Locations (2)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States