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

NCT00185848 | Completed Phase 1 DMC

• 2 other identifiers: BRNCNS000395908
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  Time of scan

Secondary Outcomes (1)

• Collection of vital signs, EKG, blood chemistry and CBC data

  day 1, 2 and 8.

Study Arms (1)

[18F]FHBG arm

EXPERIMENTAL

Radiation: [18F]FHBG

Interventions

[18F]FHBG RADIATION

\< 7mCi and 2 ug, iv

Also known as: 18F-FHBG

[18F]FHBG arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Clinical diagnosis of brain tumor or rheumatoid arthritis

You may not qualify if:

• \- Below 18 years of age

Sponsors & Collaborators

• Sanjiv Sam Gambhir: lead

Study Sites (2)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 11483684 BACKGROUND

MeSH Terms

Conditions

Brain Neoplasms; Arthritis, Rheumatoid; Central Nervous System Neoplasms; Glioma

Interventions

9-(4-fluoro-3-hydroxymethylbutyl)guanine

Condition Hierarchy (Ancestors)

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

Study Officials

• Sanjiv Sam Gambhir M.D., Ph.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: April 1, 2005
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

US (2)