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
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

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