Arthritis, Rheumatoid, Brain Cancer, Central Nervous System Neoplasms, Glioma
Conditions
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.
Interventions
RADIATION[18F]FHBG
\< 7mCi and 2 ug, iv
Sponsors
Sanjiv Sam Gambhir
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Clinical diagnosis of brain tumor or rheumatoid arthritis
Exclusion criteria
\- Below 18 years of age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study for each patient is acquisition of PET/CT image. | Time of scan |
Secondary
| Measure | Time frame |
|---|---|
| Collection of vital signs, EKG, blood chemistry and CBC data | day 1, 2 and 8. |
Countries
United States
Outcome results
None listed