This study proposes 6 anatomic groupings which each can be defined similarly as the "head and neck" grouping above. These 6 groupings are: (1) Head and Neck, (2) Thoracic not including lung parenchymal, (3) Hepatobiliary and other non-hepatobiliary abdominal tumors, (4) Retroperitoneal, (5) Pelvic, and (6) Distributed or orphan. The study is designed to gather essential imaging data on the RefleXion Medical Radiotherapy System (RMRS) to validate the accuracy of FDG-directed BgRT, also known as SCINTIX therapy, in various anatomical groupings. Study subjects will go through the entire SCINTIX treatment workflow, including radiopharmaceutical administration and live PET imaging, but without turning on the treatment beam. Collected data will be used offline to generate the set of machine instructions that would have been used during treatment delivery to calculate the "emulated" BgRT dose distribution, i.e., what the delivered dose would have been had the treatment beam been turned on during the session. The 6th category ("Distributed or orphan") is meant to capture tumor types that can manifest across anatomies and/or for which utilization of stereotactic radiotherapy for treatment is relatively rare, with lymphomas being a prototypical example.
Age greater than 21 years.
A new or prior diagnosis of biopsy-proven cancer.
At least one active non-osseous primary or metastatic tumor that is located in one of the assigned anatomical groupings and dispositioned to undergo 3-5 fractions of SBRT. A lesion is considered active if viable malignancy is confirmed either by biopsy or by diagnostic imaging (as interpreted by the multidisciplinary care team).
Target tumor size ≥2cm and ≤5cm.
Clinically significant blood glucose abnormalities that preclude a satisfactory FDG PET/CT scan.
Lung parenchymal and bone target tumors
3 cm from target on diagnostic PET/CT in directions where limited target motion is expected
4 cm from target on diagnostic PET/CT in directions where sizable target motion is expected
Sequential
RefleXion X1 Radiotherapy System [Imaging Only]
DevicekVCT and FDG-PET imaging using the RefleXion X1 Radiotherapy System in different anatomical regions
6
Treatment groupsSee each treatment group below.
Emulated BgRT Delivery accuracy
The percent of radiotherapy fractions where the emulated BgRT dose distribution is shown to be consistent with the approved BgRT treatment plan (i.e., 95% of DVHDelivered points for the BTZ and OAR fall within bounded DVH of the approved BgRT plan).
BgRT deliverability
Percent of fractions where there is concordance between physical and digital phantoms of emulated BgRT delivery derived from human subject PET emissions. Concordance is defined as a standard gamma index of 90% of pixels meeting the 3mm/3% deviation standard.
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