At a glance

ClinicalIndex Comparison Record

N/ACompleted· 30 enrolled

Drug / intervention

RMRS IDE Devicedevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04788147

NCT04788147N/ACompleted

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

RefleXion Medical·interventional·Posted Mar 9, 2021·Updated Oct 31, 2023

In Brief

A clinical study evaluating RMRS IDE Device for Cancer and 5 related conditions. Completed, enrolled 30 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCancer, Tumor, Solid, Cancer, Lung, Cancer, Bone, Metastasis to Lung, Metastasis to Bone

CountriesUnited States

Collaborators--

Timeline

N/ACompletedFinished

20222023202420252026

First PostedMar 2021

Enrollment StartMar 2021

Primary CompletionDec 2021

TodayJul 2026

First PostedMar 9, 2021

Enrollment StartMar 26, 2021

Primary CompletionDec 20, 2021

TodayJul 2, 2026

Enrollment to primary: 9 monthsPosted 5.3 years ago

Interventions

RMRS IDE Devicedevice

Participants will be injected with FDG at the studied dose and will undergo imaging sessions using the RMRS IDE device and a third-party Positron Emission Tomography (PET)/CT imaging device.