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

NCT ID: NCT00185848

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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.

Conditions

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Brain Cancer Arthritis, Rheumatoid Central Nervous System Neoplasms Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[18F]FHBG arm

Group Type EXPERIMENTAL

[18F]FHBG

Intervention Type RADIATION

\< 7mCi and 2 ug, iv

Interventions

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[18F]FHBG

\< 7mCi and 2 ug, iv

Intervention Type RADIATION

Other Intervention Names

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18F-FHBG

Eligibility Criteria

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Inclusion Criteria

\- Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion Criteria

\- Below 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanjiv Sam Gambhir

OTHER

Sponsor Role lead

Responsible Party

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Sanjiv Sam Gambhir

Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sanjiv Sam Gambhir M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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University of California Los Angeles

Los Angeles, California, United States

Site Status

Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11483684 (View on PubMed)

Other Identifiers

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95908

Identifier Type: OTHER

Identifier Source: secondary_id

BRNCNS0003

Identifier Type: OTHER

Identifier Source: secondary_id

BRNCNS0003

Identifier Type: -

Identifier Source: org_study_id

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