Daily Imaging, Target Identification, and Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow in a Novel Ring Gantry Radiotherapy Device

Overview

The investigators propose here to evaluate the feasibility of a novel cone-beam CT (CBCT)-guided online adaptive radiotherapy (ART) workflow on the Halcyon device.

Full Title of Study: “A Pilot Study of Daily Imaging, Target Identification, and Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow in a Novel Ring Gantry Radiotherapy Device”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 8, 2022

Interventions

  • Device: Ring gantry kV-CBCT combined with linear accelerator
    • Each imaging session will be less than one hour, and is expected to take no more than 15 minutes.

Arms, Groups and Cohorts

  • Experimental: Halcyon kV CBCT imaging
    • -Each patient will undergo five Halcyon kV CBCT imaging sessions that will then be utilized to simulate the CBCT-guided online ART workflow. Halcyon imaging will be scheduled as per the patient’s schedule and availability, with intent but not mandate for imaging on the same days as clinical treatments, preceding clinical treatment. Multiple images may be acquired in one session but no more than 6 Halcyon kV CBCT images will be acquired per day. No more than 6 additional Halcyon kV CBCT images will be acquired in one imaging session and no more than 10 total additional Halcyon kV CBCT images for the duration of the study

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility of the device as measured by successful completion of the full CBCT-guided online ART workflow, from volumetric imaging through phantom delivery in at least 90% of attempted fractions
    • Time Frame: Completion of ART workflow in all enrolled participants (estimated to be 30 months)

Participating in This Clinical Trial

Inclusion Criteria

  • At least one disease site deemed to be suitable for simulated treatment with online adaptive radiotherapy per radiation oncology evaluation. – Scheduled to receive radiation therapy to the thorax (n = 8), pancreas (n = 8), non-pancreas abdomen (n = 8), or pelvis (n = 8). – At least 18 years of age – Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria:

  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol PI, documentation of this exception is sufficient in lieu of a pregnancy test.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Collaborator
    • Varian Medical Systems
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lauren Henke, M.D., Principal Investigator, Washington University School of Medicine

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