PET/X LLC — Department of Health and Human Services STTR Phase I: 102

Description

The goal of this project is to develop a quantitative molecular breast imaging PET QMBI PET scanner to improve the way in which breast cancer therapies are matched to individual patients by providing evaluation of therapy efficacy during the window of opportunity between diagnosis and surgical resection More than women in the US with invasive disease start therapy for breast cancer each year In approximately deaths will result from breast cancer Unfortunately despite the successes of targeted therapies the relapse rate in patients expressing the targets and receiving these therapies still approaches for certain phenotypes The drugs can be very costly and carry toxic side effects There are currently FDA approved breast cancer drugs the most of any cancer PET holds great promise to improve therapy selection thereby sparing patients from ultimately ineffective drugs and directing them more quickly to effective regimens thus improving patient outcomes and reducing costs via a more efficient therapy selection process However all of the studies thus far using PET to assess therapy response have been limited to the quantitative accuracy of clinical whole body PET scanners A compact lower cost high resolution and quantitatively accurate PET imaging scanner will help inform the physicianandapos s choices of effective therapies for breast cancer patients Early evaluation of a therapyandapos s effectiveness will help the treating physician individualize a patientandapos s treatment In the neo adjuvant setting or the window of opportunity between diagnosis and surgery a baseline pre treatment PET image will be taken then after a short regimen of a targeted therapy a second PET scan will be used to evaluate response to treatment This will be used to guide selection and aggressiveness of post surgery therapy For this treatment paradigm to become broadly accepted and widely used the minimum viable commercial scanner needs to be higher resolution more compact and less expensive than standard whole body PET scanners In addition a high level of quantitative accuracy is needed We propose a high resolution quantitative molecular breast imaging PET QMBI PET scanner which uses a an advanced detector architecture and statistical based D imaging to acquire high sensitivity high resolution images The outcome of this Phase I application will be a functional laboratory tested single ring prototype scanner with initial data on clinical feasibility to provide evidence for commercialization in the following phase of this development The goal of this project is to develop a commercially viable quantitative molecular breast imaging PET QMBI PET scanner This will improve the way in which breast cancer therapies are matched to individual patients by directing them more quickly to effective therapies and will improve outcomes and reducing healthcare costs