Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634706
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
SCINTIX BgRT Using RMRS in Solid and Soft Tissue Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System in in a Variety of Solid and Soft Tissue Tumors BIOGUIDE-X2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie 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 andor for which utilization of stereotactic radiotherapy for treatment is relatively rare with lymphomas being a prototypical example
Detailed Description:
Ablative radiotherapy has become an integral tool for the treatment of primary tumors and metastatic lesions across the human body Because ablative radiotherapy techniques like stereotactic body radiotherapy SBRT and stereotactic radiosurgery SRS involve delivering high doses of radiotherapy in a few fractions they have the potential to cause serious injury to normal tissues near the target lesion Therefore a standard concern for radiation oncologists is to conformally and precisely deliver ablative radiotherapy while maximally sparing surrounding organs and tissues This goal is relevant throughout the anatomy and pertains as much to tumors in the head and neck as it does to those in the pelvis
Biology-guided radiotherapy is a novel radiotherapy delivery mechanism that achieves precision by aiming beamlets of external radiotherapy by tracking PET emissions that originate from the target after it has taken up an injected radiotracer Because the radiotherapy beamlets are guided to the tumor in real-time this technology holds strong promise for reducing margins around the target and thereby reducing normal tissue toxicities
Biology-guided radiotherapy is a novel radiotherapy delivery mechanism that achieves precision by aiming beamlets of external radiotherapy by tracking PET emissions that originate from the target after it has taken up an injected radiotracer Because the radiotherapy beamlets are guided to the tumor in real-time this technology holds strong promise for reducing margins around the target and thereby reducing normal tissue toxicities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None