CompletedNot applicableNCT04788147
Official study title

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

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.

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Key things to know

Main goalOther

This describes the study’s primary purpose.

What is being studiedRMRS IDE Device

The study team can explain what participation involves.

Who it may be forCancer · Tumor, Solid

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 31, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?RefleXion Medical

Study sponsor

01
Study overview

What this study is about

Purpose
Other
Study type
Interventional
Phase
Not applicable
Sponsor
RefleXion Medical
Interventions being studied
Device: RMRS IDE Device
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Age greater than 21 years 2. A new or prior diagnosis of biopsy-proven cancer with a solid tumor (non-hematologic, non-lymphoma) 3. At least one active tumor in the bone or lung which is either the primary tumor or metastatic lesion determined either by biopsy or imaging suspicious of active disease 4. Target tumor size ≥2cm and ≤5cm 5. Target lesion in the bone or lung that is discrete and assessed by the investigator to be FDG-avid (i.e. SUVmax≥6 on third-party diagnostic PET/CT performed within 60 days with no intervening oncologic therapies) 6. ECOG Performance Status 0-3 7. Must have completed any other oncologic therapies at least 15 days prior to planned start of study procedures (preferably 30 days) and must have no plans to initiate systemic therapy until after study follow up is complete -OR- must be recorded by physician to have an active candidate lesion that is unresponsive to ongoing systemic therapy. 8. Females of childbearing potential should have negative urine or serum pregnancy test within 14 days prior to initiation of study scans. 9. Demonstrate adequate organ function: determined by ANC, platelets, hemoglobin, with no gross hematuria 10. For Cohort II only: Patient is dispositioned to undergo SBRT to a bone or lung tumor

Reasons someone may not be able to joinExclusion criteria

1. Clinically significant blood glucose abnormalities that preclude a satisfactory FDG PET/CT scan. 2. Previous history of external radiotherapy where prior radiotherapy fields are anticipated to overlap with the radiotherapy fields required for the present study 3. Diffuse metastatic process (leptomeningeal disease, peritoneal carcinomatosis, diffuse bone marrow involvement, etc.) 4. PET-avid structures not intended for radiation are within 2cm from target on third-party diagnostic PET/CT as assessed by investigator 5. Known allergy to FDG 6. Known psychiatric or substance abuse disorder that would interfere with conduct of the study 7. Pregnant, breast-feeding or expecting to conceive during the study 8. Patient weight exceeding the weight limit outlined per IFU. 9. For Cohort II only: Patients with pacemakers and other implantable devices who are deemed to be at high risk by the treating physician for complications secondary to radiotherapy. 10. For Cohort II only: Patients with bone lesions who are determined to be high risk by the treating physician for pathologic fracture prior to beginning radiotherapy. 11. For Cohort II only: Active inflammatory bowel disease, scleroderma, or other disorder deemed to be a risk factor for excess toxicity in the area of treatment by the treating physician.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Stanford UniversityStanford, California
  • UT SouthwesternDallas, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 31, 2023. Always confirm current availability with the study team.

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