©2022 Stanford Medicine
Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X)
Not Recruiting
Trial ID: NCT04788147
Purpose
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.
Official Title
Performance and Safety of Biology-Guided Radiotherapy Using the RefleXion Medical Radiotherapy System (BIOGUIDE-X)
Stanford Investigator(s)
Steven D. Chang, MD
Robert C. and Jeannette Powell Neurosciences Professor and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Neurology
Eligibility
Inclusion 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
Exclusion 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.
Intervention(s):
device: RMRS IDE Device
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mahjabin Noroozi