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

This study has been completed.
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University Identifier:
First received: September 12, 2005
Last updated: March 12, 2017
Last verified: March 2017
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
Brain Cancer Arthritis, Rheumatoid Central Nervous System Neoplasms Glioma Radiation: [18F]FHBG Phase 1

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Sanjiv Sam Gambhir, 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 ]

Secondary Outcome Measures:
  • Collection of vital signs, EKG, blood chemistry and CBC data [ Time Frame: day 1, 2 and 8. ]

Enrollment: 10
Study Start Date: April 2005
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [18F]FHBG arm Radiation: [18F]FHBG
< 7mCi and 2 ug, iv
Other Name: 18F-FHBG

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00185848

United States, California
University of California Los Angeles
Los Angeles, California, United States, 90095
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Sanjiv Sam Gambhir
Principal Investigator: Sanjiv Sam Gambhir M.D., Ph.D. Stanford University
  More Information

Responsible Party: Sanjiv Sam Gambhir, Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research, Stanford University Identifier: NCT00185848     History of Changes
Other Study ID Numbers: BRNCNS0003
95908 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BRNCNS0003 ( Other Identifier: Stanford University )
Study First Received: September 12, 2005
Last Updated: March 12, 2017

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on September 21, 2017