The objective of this Phase I research is to demonstrate the feasibility of creating timed-bioabsorbable Pd-103 seeds for the treatment of prostate tumors. Timed- bioabsorbable seeds have the combined benefits of titanium seeds, high dose rate temporary seeds, external beam radiation and other treatment options. In addition, timed-bioabsorbable seeds potentially offer desirable post-treatment options, total bioabsorption of the implants and the lowest overall treatment cost.
The specific aims of this proposed Fast Track Phase I research are to (1) identify absorbable matrices that have appropriate intrinsic bioabsorption rates and are suitable for engineered control of bioabsorption profiles; (2) determine seed dimension for optimal imaging; (3) control the bioabsorption such that the cumulative Pd-103 radioactivity leakage from seeds is 1% or less and the complete bioabsorption of seed matrices is estimated within 2 years; (4) determine and recommend optimal matrix chemistry and bioabsorption engineering conditions for in-depth studies of Pd-103 leakages and bioabsorption profiles in the Fast-Track Phase II; and (5) demonstrate the biocompatibility for selected timed-bioabsorbable seeds in vitro using ISO methods. Achieving key and measurable milestones set in Phase I will ensure successful completion of the proposed Fast Track Phase II, leading to high impact bioabsorbable seeds for the treatment of prostate tumors and other malignant tumors. ? ? ?
