Radiation Dosimetry from Intratumoral Injection of Radionuclides in Human Breast Cancer

摘要

This study has been designed to evaluation the sequestration of proprietary radiopharmaceuticals Radioactive Gallium Iron Macroaggregates (GIMA) after intratumoral injection. Our team has adopted a 2-prong approach. While the official approval of the human protocol is ongoing, we continue on translation studies using in vivo imaging methods to investigate our institution-approved animal tumor models in rats and dogs. We made revisions the approved human protocol and received preliminary approval from the Army in March 2005, awaiting the final approval of the revisions by the MDACC IRB. Because of the de-commission of our institutional Radioactive Drug Research Committee (RDRC) in 2005, we have sought other approval avenues to conduct the human study in compliance with FDA regulation. While an IND route was in progress, our large animal tumor models in 5 dogs (>20Kg) yielded confirmatory results for sequestration of Ga-68 GIMA. The remaining scientific question is the demonstration of persistent sequestration of GIMA in human breast cancer for derivation of dosimetry. In the meantime, our institution has reapplied to the FDA to reestablish the RDRC, which will be the most appropriate authority to supervise the low-dose Ga-67 GIMA protocol of 5 patients. We expect to regain the RDRC approval within the next few months and conclude this project within 12 months.