Biodistribution and dosimetry of an aqueous solution containing sodium 3-(125I)iodo-4-hydroxybenzenesulfonate (Iotrex) for brachytherapy of resected malignant brain tumors.
Iotrex is an aqueous radiotherapy solution containing sodium 3-(125I)iodo-4-hydroxybenzenesulfonate (125I-HBS), which is used as the radiation source for the brachytherapy of resected of brain tumor cavity margins with the GliaSite catheter. During routine clinical use of this brachytherapy applicator and radiation source, approximately 0.1% of the afterloaded Iotrex will diffuse through the GliaSite balloon. Our purpose was to assess the radiation doses to normal organs under routine clinical use of the GliaSite.


METHODS
Five groups of rats received intracerebral injections of an 131I-HBS solution (131I used as a surrogate for 125I in the synthesis of 125I-HBS) with one group sacrificed at 15 minutes, 30 minutes, 1 hour, 2 hours and 4 hours post-administration. Urine was collected and activity retention in numerous organs was measured. The biodistribution data were used to estimate radiation doses to normal organs of the Reference Adult Male and Female phantoms.


RESULTS
Radioactivity was rapidly and completely cleared from the brain (98% cleared by 2 hours) and total body (urinary clearance; 93%@2 hours). No organ retained > 0.7% of the radioactivity at 4 hours. For 100% loss of the radiotherapy solution from the balloon catheter (device failure), all organs would receive less than 100 mGy (10 rad), except the bladder wall (2800 mGy, 280 rad), uterus (130 mGy, 13 rad) and distal colon (270 mGy, 27 rad). Under normal conditions, all organ doses are 1000-fold lower (< 3 mGy or 0.3 rad).


CONCLUSIONS
Under routine clinical conditions, the radiation doses to normal organs are inconsequential. Should the maximum clinical load of Iotrex (16.7 GBq of 125I) be released intracerebrally, the radiation doses to all organs would be below the thresholds for deterministic effects.
Stubbs
J B
JB
Proxima Therapeutics, Inc., 2555 Marconi Drive, Suite 220, Alpharetta, GA 30005, USA. jstubbs@proximatherapeutics.com
Strickland
A D
AD
Frank
R K
RK
Simón
J
J
McMillan
K
K
Williams
J A
JA
D000818:Animals; D001557:Benzenesulfonates / Q000493:pharmacokinetics* / Q000627:therapeutic use; D001918:Brachytherapy; D001921:Brain / Q000378:metabolism* / Q000528:radiation effects; D001932:Brain Neoplasms / Q000378:metabolism / Q000532:radiotherapy*; D008297:Male; D015233:Models, Statistical; D011874:Radiometry; D051381:Rats; D017207:Rats, Sprague-Dawley; D014018:Tissue Distribution
D001557:Benzenesulfonates; C421459:iotrex