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

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT04008537
Collaborator
Varian Medical Systems (Industry)
37
Enrollment
1
Location
1
Arm
30.1
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Ring gantry kV-CBCT combined with linear accelerator
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
A Pilot Study of Daily Imaging, Target Identification, and Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow in a Novel Ring Gantry Radiotherapy Device
Actual Study Start Date :
Sep 4, 2019
Actual Primary Completion Date :
Mar 8, 2022
Actual Study Completion Date :
Mar 8, 2022

Arms and Interventions

Arm Intervention/Treatment
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

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.
Other Names:
  • Halcyon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [Completion of ART workflow in all enrolled participants (estimated to be 30 months)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine
    • Varian Medical Systems

    Investigators

    • Principal Investigator: Lauren Henke, M.D., Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT04008537
    Other Study ID Numbers:
    • 201908024
    First Posted:
    Jul 5, 2019
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Pelvic Neoplasms

    Study Results

    No Results Posted as of Apr 19, 2022