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NCT Number: NCT00185848

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

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.

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Key information

Conditions

Brain Cancer Arthritis Arthritis, Rheumatoid Autoimmune Diseases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Connective Tissue Diseases Glioma Immune System Diseases Joint Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California Los Angeles, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion criteria

  • Below 18 years of age

Treatment and study plan

[18F]FHBG

Radiation

< 7mCi and 2 ug, iv

Other names: 18F-FHBG

Primary outcomes

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

    Time frame: Time of scan

Secondary outcomes

  1. Collection of vital signs, EKG, blood chemistry and CBC data

    Time frame: day 1, 2 and 8.

Sponsors and collaborators

Lead sponsor

Sanjiv Sam Gambhir

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2005
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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