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

This study is ongoing, but not recruiting participants.

First Received: September 12, 2005 Last Updated: November 9, 2009 History of Changes

Sponsor:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00185848

Purpose

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	Intervention	Phase
Central Nervous System Neoplasms Brain Cancer Glioma Arthritis, Rheumatoid	Procedure: [18F]FHBG	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Imaging the Biodistribution of the Positron Emission Tomography Reporter Probe, [18F]FHBG, in Humans.

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Estimated Enrollment:	10
Study Start Date:	April 2005
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Exclusion Criteria:- Below 18 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185848

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

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

Stanford University

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:	Stanford University School of Medicine ( Sanjiv Sam Gambhir M.D., Ph.D. )
Study ID Numbers:	BRNCNS0003, 95908, BRNCNS0003, NCT00185848
Study First Received:	September 12, 2005
Last Updated:	November 9, 2009
ClinicalTrials.gov Identifier:	NCT00185848 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Neoplasms, Nerve Tissue
Nervous System Diseases
Arthritis, Rheumatoid
Central Nervous System Diseases
Central Nervous System Neoplasms
Rheumatic Diseases
Brain Diseases
Neuroectodermal Tumors

Brain Neoplasms
Neoplasms
Neoplasms by Site
Musculoskeletal Diseases
Neoplasms, Germ Cell and Embryonal
Arthritis
Connective Tissue Diseases
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009