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

Primary Purpose

Any Solid Malignancies of Any Tissue Origin (Except for Small Cell Lung Cancer) Involving the Upper Abdomen and Thorax

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ETHOS

CT-guided stereotactic adaptive radiotherapy

About this trial

This is an interventional treatment trial for Any Solid Malignancies of Any Tissue Origin (Except for Small Cell Lung Cancer) Involving the Upper Abdomen and Thorax

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CT-guided stereotactic adaptive radiotherapy

Arm Description

-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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05030454

First Posted

August 19, 2021

Last Updated

March 27, 2023

Sponsor

Washington University School of Medicine

Collaborators

Varian Medical Systems

1. Study Identification

Unique Protocol Identification Number

NCT05030454

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 19, 2021 (Actual)

Primary Completion Date

March 17, 2022 (Actual)

Study Completion Date

July 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

Varian Medical Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Any Solid Malignancies of Any Tissue Origin (Except for Small Cell Lung Cancer) Involving the Upper Abdomen and Thorax

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CT-guided stereotactic adaptive radiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

ETHOS

Intervention Description

Ring-gantry CT-guided radiotherapy unit, pairing a linear accelerator within a ring-gantry imaging unit.

Intervention Type

Radiation

Intervention Name(s)

CT-guided stereotactic adaptive radiotherapy

Intervention Description

All participants will be initially planned to at least 35 Gy in 5 fractions, subject to hard constraints based on the treatment site.

Primary Outcome Measure Information:

Title

Percentage of Scheduled Treatment Fractions Delivered Successfully Using the Surface Guidance System

Description

Time Frame

Through completion of treatment (estimated to be 2 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela Samson, M.D., MPHS

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

http://www.siteman.wustl.edu

Description

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

Learn more about this trial

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

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