Radiation Dosimetry of Intratumoral Injection of Radionuclides into Human Breast Cancer. Revision
Abstract
This study has been designed to evaluate the spatial and temporal distribution as well as the radiation dosimetry of intratumoral injection of proprietary radiopharmaceuticals Ga-67 and Ga-68 Galium Iron Macroaggregates (GIMA). While the refinement of the human protocol is ongoing, we continued on basic studies of in vivo imaging and therapy using other drugs under revised versions of our approved rat tumor protocols. We gained approval of our canine tumor model protocol by the Army Animal Research Committee. Seven canine studies have confirmed the prolonged loculation of tumors after injection of Ga-67 GIMA. However, we also encountered organ- specific technical challenges that may not be relevant to human breast cancer. In preparation of the clinical trial, we gained approval of our human protocol 2005-0219 by our institutional IRB, pending final approval of federal regulatory processes. Initial contact with the FDA officials indicated that RDRC route was not the preferred route. We have therefore engaged our institutional IND committee to assist our application for IND/eIND. We have developed specific QA procedures for Ga-67 GIMA and engaged an outside radiopharmaceutical vendor for manufacturing, quality control as well as toxicology testing. We expect to be able to provide the necessary data for regulatory approval within the next year.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2007
- Accession Number
- ADA501872
Entities
People
- Franklin C. Wong
Organizations
- The University of Texas MD Anderson Cancer Center