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

Sanjiv Sam Gambhir

Status and phase: Completed; Phase 1

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

Treatments: Radiation: [18F]FHBG

Study type: Interventional

Funder types: Other

Identifiers

NCT00185848

BRNCNS0003 (Other Identifier)

95908 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of brain tumor or rheumatoid arthritis

Exclusion criteria

• Below 18 years of age

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

[18F]FHBG arm

Experimental group

Treatment:

Radiation: [18F]FHBG