NCI-sponsored trial for the evaluation of safety and preliminary efficacy of FLT as a marker of proliferation in patients with recurrent gliomas: safety studies.
OBJECTIVE
3'-[F-18]Fluoro-3'-deoxythymidine (FLT) is an analog of thymidine that is being developed for imaging cellular proliferation. The goal of this study was to prove that the dose of FLT used for positron emission tomography imaging produces no significant toxicity.


METHODS
Twelve patients with gliomas with either recurrence or suspected radionecrosis were imaged with FLT. Before and at several time points after imaging, subjects underwent general physical and neurological examinations with review of systems and tests of hematologic, hepatic, renal, and several other metabolic parameters. Vital signs and electrocardiograms were monitored during and after the imaging session.


RESULTS
There were no significant adverse effects from FLT injected at a dose of 0.07 mCi/kg (maximum of 5 mCi) at specific activities of 1.25 Ci/micromol or higher. The FLT mass administered for imaging was 0.0001% to 0.0009% of the least toxic cumulative dose administered in clinical trials of FLT as an antiretroviral agent.


CONCLUSIONS
FLT is a safe radiotracer for quantifying proliferation in the human cancer setting.
Department of Neurology, University of Washington, Box 356465, 1959 NE Pacific Street, Seattle, WA 98195-6004, USA. aspence@u.washington.edu
Alexander M
AM
Spence
Mark
M
Muzi
Jeanne M
JM
Link
John M
JM
Hoffman
Janet F
JF
Eary
Kenneth A
KA
Krohn
D000328:Adult; D015415:Biomarkers; D002245:Carbon Dioxide / Q000097:blood; D049109:Cell Proliferation; D003401:Creatine / Q000378:metabolism; D015224:Dideoxynucleosides / Q000378:metabolism*; D064420:Drug-Related Side Effects and Adverse Reactions; D004562:Electrocardiography; D005260:Female; D005910:Glioma / Q000175:diagnosis* / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D054547:National Cancer Institute (U.S.); D009364:Neoplasm Recurrence, Local / Q000175:diagnosis* / Q000378:metabolism; D049268:Positron-Emission Tomography; D011188:Potassium / Q000097:blood; D014481:United States
D015415:Biomarkers; D015224:Dideoxynucleosides; D002245:Carbon Dioxide; D003401:Creatine; C002854:alovudine; D011188:Potassium