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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

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ClinicalTrials.gov Identifier: NCT00185848
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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 : April 2005
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion Criteria:

- Below 18 years of age


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185848


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

Publications:
Responsible Party: Sanjiv Sam Gambhir, Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research, Stanford University
ClinicalTrials.gov Identifier: NCT00185848     History of Changes
Other Study ID Numbers: BRNCNS0003
95908 ( Other Identifier: Stanford University Alternate IRB Approval Number )
BRNCNS0003 ( Other Identifier: Stanford University )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Arthritis
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
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases