Radiation Dosimetry of Intratumoral Injection of Radionuclides into Human Breast Cancer
Abstract
This study has been designed to evaluation the spatial and temporal distribution as well as the radiation dosimetry of intratumoral injection of proprietary radiopharmaceuticals Ga-67 and Ga-68 Gallium Iron Macroaggregates (GIMA). Our team has adopted a 2-prong approach for this study. While the refinement of the human protocol is ongoing, we continue on basic studies to investigate in vivo imaging methods and effects of other drugs under revised versions of our approved animal protocol. During this last year, we have gained the approval of our human protocol by our institutional IRB. We also worked along with recommendations from the Army for the approval of our human protocol by the Army Human Subject Protection Committee. We made revisions the approved human protocol and received preliminary approval from the Army since March 2005, awaiting the final approval of the revisions by the MDACC IRB. However, because of developments in our own institution, the committee overseeing our use of radioactive drug is no longer in operation. Our team has started to redirect our efforts to seek other approved avenues to conduct the human study in compliance with FDA regulation. Currently we are working on IND-approval processes and expect to initiate human studies within the next year.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2005
- Accession Number
- ADA448359
Entities
People
- Franklin C. Wong
Organizations
- The University of Texas MD Anderson Cancer Center