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

• Sponsor: Sanjiv Sam Gambhir (Other)
• Overall Status: Completed
• CT.gov ID: NCT00185848
• Collaborator: (none)
• Enrollment: 10
• Locations: 2
• Arm: 1
• Duration (Months): 98
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Cancer; Arthritis, Rheumatoid; Central Nervous System Neoplasms; Glioma	Radiation: [18F]FHBG	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Imaging the Biodistribution of the Positron Emission Tomography Reporter Probe, [18F]FHBG, in Humans.
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [18F]FHBG arm	Radiation: [18F]FHBG; < 7mCi and 2 ug, iv; Other Names: 18F-FHBG

Outcome Measures

Primary Outcome Measures

1. The primary endpoint of the study for each patient is acquisition of PET/CT image. [Time of scan]

Secondary Outcome Measures

1. Collection of vital signs, EKG, blood chemistry and CBC data [day 1, 2 and 8.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion Criteria:

• Below 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles	Los Angeles	California	United States	90095
2	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Sanjiv Sam Gambhir

Investigators

• Principal Investigator: Sanjiv Sam Gambhir M.D., Ph.D., Stanford University

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Sanjiv Sam Gambhir, Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research, Stanford University
• ClinicalTrials.gov Identifier: NCT00185848
• Other Study ID Numbers: BRNCNS0003; 95908; BRNCNS0003
• First Posted: Sep 16, 2005
• Last Update Posted: Mar 14, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Brain Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Mar 14, 2017