SCINTIX [BgRT} Using RMRS in Solid and Soft Tissue Tumors

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorRefleXion Medical

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • RefleXion X1 Radiotherapy System [Imaging Only]

Treatment groups

96 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators