Daily Imaging, Target Identification, And Simulated Computed Tomography-Based Stereotactic Adaptive Radiotherapy Workflow In A Novel Ring Gantry Radiotherapy Device

Study Overview

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.

N/A

Cancer of Pancreas
Cancer of Pelvis
Cancer of Abdomen
Cancer of Thorax

DEVICE: Ring gantry kV-CBCT combined with linear accelerator

201908024

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-06-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-04-18
First Submitted that Met QC Criteria 2019-07-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-04-19
First Posted (ACTUAL) 2019-07-05	Results First Posted N/A	Last Verified 2022-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Device Feasibility

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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	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.

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

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.

Primary Outcome Measures	Measure Description	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)

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Varian Medical Systems

Investigators

PRINCIPAL_INVESTIGATOR: Lauren Henke, M.D., Washington University School of Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record