Novel Optical Surface Image Guidance System for Beam-Gated Online Adaptive SBRT Delivery in Mobile Lower Lung and Upper Abdominal Malignancies

Pilot Study of a Novel Optical Surface Image Guidance System for Beam-Gated Online Adaptive SBRT Delivery in Mobile Lower Lung and Upper Abdominal Malignancies

Motion during radiation therapy can be categorized as inter-fraction (changes in anatomy that occur between treatment days) and intra-fraction (changes that occur during the "beam on" window of treatment delivery). Inter-fraction motion is managed by adaptive radiotherapy (ART), the process of making changes in the treatment plan while the patient remains on the treatment table. This is now a standard-of-care therapy within Washington University's clinic. Intra-fraction motion is managed by gated and non-gated delivery techniques. Varian Medical Systems has integrated the necessary components into a CT-guided radiotherapy device (ETHOS). In the ETHOS, Varian has built a device that integrates on-board cone beam CT imaging capable of delineating target and organ-at-risk positions and a dedicated artificial intelligence-driven treatment planning system for inter-fraction motion management as well as a paired optical surface image guidance system for intra-fraction motion management. Although online ART is a standard-of-care practice in the clinic and has previously been shown to be feasible, use of surface-guidance for intra-fraction gating of abdominal and thoracic SBRT on ETHOS is novel.

Therefore, in this study, the investigators propose to evaluate the feasibility and safety of using a novel surface guidance beam-gating system, incorporated with a CBCT-guided adaptive radiotherapy platform, to manage respiratory motion during delivery of CT-guided stereotactic radiotherapy. To best assess the utility of this technology to manage respiratory motion, the investigators will focus on disease sites that are highly affected by respiratory motion: upper abdominal or lower thoracic malignancies.

Study Overview

• Status: Completed
• Conditions: Any Solid Malignancies of Any Tissue Origin (Except for Small Cell Lung Cancer) Involving the Upper Abdomen and Thorax
• Intervention / Treatment: Device: ETHOS; Radiation: CT-guided stereotactic adaptive radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 10
• 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

Description

Inclusion Criteria:

• Primary or metastatic disease of the abdomen or lower thorax, with biopsy-proven or radiographically diagnosed disease histology of solid tumor categorization, with the exception of small cell cancers.
• Must be medically fit for SBRT as determined by the treating physician, with at least one disease site to be deemed suitable for treatment with CT-guided stereotactic radiation to the abdomen or thorax as per radiation oncologist evaluation.
• At least 18 years of age.
• Karnofsky performance status > 60
• Capable of single deep inspiratory breath-hold or end-exhale breath-hold of at least 17 seconds in duration and of repeated end-exhale or deep inspiratory breath-hold of at least 10 seconds in duration upon verbal instruction.
• Must have completed any systemic therapy at least one week prior to planned start of SBRT (two weeks preferred), and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred).
• Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

• Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by CT-guided SBRT.
• Currently receiving any investigational agents.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 14 days of study entry.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-guided stereotactic adaptive radiotherapy; -Radiotherapy will consist of stereotactic body therapy, to be given over five fractions, delivered once daily or once every other day for a period of one to two weeks, for a total of five treatments.	Device: ETHOS; Ring-gantry CT-guided radiotherapy unit, pairing a linear accelerator within a ring-gantry imaging unit.; Radiation: CT-guided stereotactic adaptive radiotherapy; All participants will be initially planned to at least 35 Gy in 5 fractions, subject to hard constraints based on the treatment site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Scheduled Treatment Fractions Delivered Successfully Using the Surface Guidance System	Success will be defined as delivery of a given treatment fraction in one on-table attempt, without requiring use of a secondary (backup) motion management system, or alternative treatment machine. Unsuccessful delivery of a fraction will be defined as multiple attempts for gating without reproducible positioning, breath-hold, and/or surface guidance feedback, such that the fraction is abandoned.	Through completion of treatment (estimated to be 2 weeks)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Varian Medical Systems
• Investigators: Principal Investigator: Pamela Samson, M.D., MPHS, 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): October 19, 2021
• Primary Completion (Actual): March 17, 2022
• Study Completion (Actual): July 7, 2022

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: 202107198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) that will be used for individual participant data meta-analysis.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals may be submitted to the primary contact for this study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

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