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

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

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 16, 2005
• Last Update Posted Date: March 14, 2017
• Study Start Date: April 2005
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 9, 2009): The primary endpoint of the study for each patient is acquisition of PET/CT image. [ Time Frame: Time of scan ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: November 9, 2009): Collection of vital signs, EKG, blood chemistry and CBC data [ Time Frame: day 1, 2 and 8. ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessing the Suitability of an Imaging Probe for Use in Clinical Cell and Gene Therapy Trials in Cancer and Rheumatoid Arthritis
• Official Title: 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Brain Cancer
• Arthritis, Rheumatoid
• Central Nervous System Neoplasms
• Glioma

Intervention

Radiation: [18F]FHBG

< 7mCi and 2 ug, iv

Other Name: 18F-FHBG

Study Arms

Experimental: [18F]FHBG arm

Intervention: Radiation: [18F]FHBG

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 12, 2005): 10
• Original Enrollment: Same as current
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

- Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion Criteria:

- Below 18 years of age

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00185848
• Other Study ID Numbers: BRNCNS0003; 95908 ( Other Identifier: Stanford University Alternate IRB Approval Number ); BRNCNS0003 ( Other Identifier: Stanford University )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Sanjiv Sam Gambhir, Stanford University
• Study Sponsor: Sanjiv Sam Gambhir
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sanjiv Sam Gambhir M.D., Ph.D.; Stanford University

• PRS Account: Stanford University
• Verification Date: March 2017