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NCT04788147 · ClinicalTrials.gov registry record · NA
Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X)
A NA study, sponsored by RefleXion Medical.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT04788147: Completed NA study, sponsored by RefleXion Medical.
NCT04788147 is a NA study that has completed, run by RefleXion Medical. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04788147, a NA study, has completed, sponsored by RefleXion Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
The primary endpoint determined the number of cases that received the lowest FDG dose of 15 mCi, completed the RMRS image session and established an adequate target activity concentration to enable Biology guided Radiotherapy planning. The starting dose was 15mCi which was determined based upon preliminary physics studies done prior to this study. A FDG dose escalation to 20 mCi was not required.
Interventions
- DEVICE RMRS IDE Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-03-26 |
| Est. Completion | 2021-12-20 |
| Phase | NA |
What the finished NCT04788147 record still lists
NCT04788147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which RMRS IDE Device is the first listed.
NCT04788147 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04788147 about?
NCT04788147 is a clinical study titled "Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X)". 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...
What is the current status of trial NCT04788147?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2021-03-26. Estimated completion is 2021-12-20.
What interventions are being tested in trial NCT04788147?
The interventions under investigation include: RMRS IDE Device (DEVICE).
Who is sponsoring clinical trial NCT04788147?
This trial is sponsored by RefleXion Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04788147's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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