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Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X)

ClinicalTrials.gov · COMPLETED, 2021

30 participants

Abstract

The purpose of this study is to assess the performance and safety of Biology-Guided Radiotherapy (BgRT) using the RefleXion Medical Radiotherapy System (RMRS) via optimizing F18-Fluorodeoxyglucose (FDG) dosing, assessing the performance of the Positron Emission Tomography (PET) imaging subsystem for BgRT treatment planning and delivery, including its role as an interlock, and validating the dose delivery performance of the end-to-end BgRT workflow.

Conditions: Cancer, Tumor, Solid, Cancer, Lung, Cancer, Bone, Metastasis to Lung, Metastasis to Bone.

Primary outcome: Cohort I Recommended RefleXion FDG Dose (RRFD) to Enable the Use of BgRT Planning.; Cohort II: Delivery Emulation.

Enrollment: 30 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 30 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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