Seeking additional funding: A primary goal of our research is to identify and incorporate imaging techniques which will allow us to more accurately determine where the most aggressive disease is located. This means we can personalize patient care by targeting these specific regions and possibly spare more healthy tissue if we do not have,to use the large margins required with conventional imaging where we know there is diseased tissue beyond what we’re able to see.
Our initial research has focused on first validating that 18F-FDOPA-PET imaging correlates with pathology, and our preliminary results have clearly demonstrated this imaging technique is able to show regions of aggressive disease not seen with conventional imaging. Based on these results we believe radiation therapy target volumes defined per conventional imaging are under-treating regions of highly aggressive disease. While we continue to accrue patients for the initial biopsy study funded by the BTFC grant, we are seeking additional funding to pilot the next phase of our research. This next phase will involve incorporating 18F-FDOPA-PET imaging into target volume delineation for radiation therapy, and studying if the change in our target volumes will improve individual patient outcomes. Patterns of failure will be correlated with tumor extent treated with the addition of 18F-FDOPA-PET imaging and previously treated volumes based solely on conventional MRI volumes. Specifically, patients will be followed to determine if the addition of 18F-FDOPA-PET imaging for treatment planning increases the time to progression and/or improves patient survival. In order to use 18F-FDOPA-PET in a diagnostic fashion, i.e. to include that information when defining the radiation target volume, the FDA requires that we submit an lnvestigational New Drug (IND) application (please see the budget and budget justification, attachments C and D). The continued support of BTFC would allow us to apply for the IND, and to run a second pilot study in which patients will undergo an 18F-FDOPA-PET scan just prior to radiation treatment planning. Patients in the initial biopsy-correlation study will be also eligible for the proposed treatment planning study, but this second pilot study will also be open to patients who did not or could not participate in the biopsycorrelation study. We also plan to acquire advanced MR imaging for these glioma patients. Advanced imaging techniques such as perfusion and diffusion MRI will allow us to further study the underlying structure of brain tum,ors and can provide additional information about tumor grade and extent.
In addition to bringing us closer to individualizing radiation target volumes, the continued support of BTFC would help secure extramural funding for future research with a larger patient population. We are actively seeking extramural funding and have recently been selected by the Mayo Cancer Center to apply for the National Brain Tumor Society Innovation Grant Award. In addition we are currently writing a National Institutes of Health (NIH) Research Project Grant (R0l). The R0l will incorporate 8F-FDOPA-PET imaging data with additional advanced MR imaging of gliomas including on a large scale both a neurosurgery component as funded initially by BTFC as well as a radiation treatment planning and outcomes component as proposed in pilot form here.
Once again we thank you for the generosity you have shown us, and we hope to continue this productive collaboration in the future.