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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer of Pancreas; Cancer of Thorax; Cancer of Pelvis; Cancer of Abdomen
• Intervention / Treatment: Device: Ring gantry kV-CBCT combined with linear accelerator

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Varian Medical Systems
• Investigators: Principal Investigator: Lauren Henke, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 4, 2019
• Primary Completion (ACTUAL): March 8, 2022
• Study Completion (ACTUAL): March 8, 2022

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (ACTUAL): July 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Pelvic Neoplasms
• Other Study ID Numbers: 201908024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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