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

NCT05030454 | Completed Results DMC FDA Device

• 1 other identifier: 202107198
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

CT-guided stereotactic adaptive radiotherapy

EXPERIMENTAL

-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; Radiation: CT-guided stereotactic adaptive radiotherapy

Interventions

ETHOS DEVICE

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

CT-guided stereotactic adaptive radiotherapy

CT-guided stereotactic adaptive radiotherapy RADIATION

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

CT-guided stereotactic adaptive radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Kiser K, Schiff J, Laugeman E, Kim T, Green O, Hatscher C, Kim H, Badiyan S, Spraker M, Samson P, Robinson C, Price A, Henke L. A feasibility trial of skin surface motion-gated stereotactic body radiotherapy for treatment of upper abdominal or lower thoracic targets using a novel O-ring gantry. Clin Transl Radiat Oncol. 2023 Oct 23;44:100692. doi: 10.1016/j.ctro.2023.100692. eCollection 2024 Jan.

  PMID: 38021090 DERIVED

Related Links

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

Results Point of Contact

• Title: Pamela Samson, M.D., MPHS
• Organization: Washington University School of Medicine

psamson@wustl.edu

314-747-1786

Study Officials

• Pamela Samson, M.D., MPHS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 1, 2021
• Study Start: October 19, 2021
• Primary Completion: March 17, 2022
• Study Completion: July 7, 2022
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• 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.

Locations

US (1)