Preclinical Imaging and Treatment of Pancreatic Cancer
The aim of this project is to determine the optimal treatment conditions for ultrasound- and microbubble- guided drug delivery in pancreatic cancer.
The addition of ultrasound- and microbubble- guidance to the tradition therapy, is expected to inhibit tumour growth, delay metastatic development, leading to extended survival.
The expected distress for the animals can be considered minimal to moderate. The primary distress that the animals may undergo throughout the treatment duration is ruffled fur and weight loss. During surgical tumour engraftment there is a minimal potential risk of wound infection. In isolated cases male mice might be housed individually for a limited period of time (days, weeks) until we acquire all the experimental data we need.
The results obtained from these pre-clinical studies will directly translate into clinical practice in the form of a Phase I/II clinical trial. All methods used in this project use FDA approved techniques and technologies already available in the clinic. Our previous pilot trial let to a Phase I trial where the results indicated improved survival and an extended period of high-quality of life.
In conclusion the results of this project will have direct societal and scientific benefit improved the survival and quality of life for patients with pancreatic cancer.
A total of 494 animals will be used over a total of 4 multi-part experiments.
In preparation for this study we have performed numerous in-vitro studies using bioreactors to determine the optimal conditions. These studies have significantly reduced the number of variables needed to be examined. In this study we will used the most optimal conditions to evaluate the treatment efficacy in a dynamic environment (in vivo) versus the static environment (in vitro).
Initial pilot studies have been performed to validate the techniques and results for this therapeutic modality to prevent excessive use of animals. To ensure the results are statistically significant, preventing the need for repeat experiments, a statistical power analysis has been performed using the results from the pilot studies as the expected hazard ratio. Based on the results from the power analysis we will use the minimal amount of animals necessary.
The addition of ultrasound- and microbubble- guidance to the tradition therapy, is expected to inhibit tumour growth, delay metastatic development, leading to extended survival.
The expected distress for the animals can be considered minimal to moderate. The primary distress that the animals may undergo throughout the treatment duration is ruffled fur and weight loss. During surgical tumour engraftment there is a minimal potential risk of wound infection. In isolated cases male mice might be housed individually for a limited period of time (days, weeks) until we acquire all the experimental data we need.
The results obtained from these pre-clinical studies will directly translate into clinical practice in the form of a Phase I/II clinical trial. All methods used in this project use FDA approved techniques and technologies already available in the clinic. Our previous pilot trial let to a Phase I trial where the results indicated improved survival and an extended period of high-quality of life.
In conclusion the results of this project will have direct societal and scientific benefit improved the survival and quality of life for patients with pancreatic cancer.
A total of 494 animals will be used over a total of 4 multi-part experiments.
In preparation for this study we have performed numerous in-vitro studies using bioreactors to determine the optimal conditions. These studies have significantly reduced the number of variables needed to be examined. In this study we will used the most optimal conditions to evaluate the treatment efficacy in a dynamic environment (in vivo) versus the static environment (in vitro).
Initial pilot studies have been performed to validate the techniques and results for this therapeutic modality to prevent excessive use of animals. To ensure the results are statistically significant, preventing the need for repeat experiments, a statistical power analysis has been performed using the results from the pilot studies as the expected hazard ratio. Based on the results from the power analysis we will use the minimal amount of animals necessary.