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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

November 9, 2009

Start Date ^ICMJE

April 2005

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint of the study for each patient is acquisition of PET/CT image. [ Time Frame: Time of scan ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00185848 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Collection of vital signs, EKG, blood chemistry and CBC data [ Time Frame: day 1, 2 and 8. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Single Group Assignment

Condition ^ICMJE

Central Nervous System Neoplasms
Brain Cancer
Glioma
Arthritis, Rheumatoid

Intervention ^ICMJE

Procedure: [18F]FHBG

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:- Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion Criteria:- Below 18 years of age

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00185848

Responsible Party

Sanjiv Sam Gambhir M.D., Ph.D., Stanford University School of Medicine

Study ID Numbers ^ICMJE

BRNCNS0003, 95908, BRNCNS0003, NCT00185848

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Sanjiv Sam Gambhir M.D., Ph.D.

Stanford University

Information Provided By

Stanford University

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP