Patient Position Monitoring System for Beam Gated Radiation Therapy of Malignancies of the Chest and Upper Abdomen

Pilot Study of a Novel Patient Position Monitoring System for Beam Gated Radiation Therapy of Malignancies of the Chest and Upper Abdomen

This study will evaluate the feasibility of using this novel patient position monitoring system for patients receiving radiation therapy to targets involving the chest or upper abdomen, as these are the most affected by respiratory motion. This motion monitoring system will be incorporated with standard of care on-board CT imaging to confirm that the respiratory position is tracking the tumor target appropriately.

Study Overview

• Status: Recruiting
• Conditions: Radiotherapy; Radiotherapy, Image-Guided
• Intervention / Treatment: Device: Patient Position Monitoring System

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Pamela Samson, MD, MPHS; Phone Number: 314-801-3806; Email: psamson@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Pamela Samson, MD, MPHS; Phone Number: 314-801-3806; Email: psamson@wustl.edu
      • Principal Investigator: Pamela Samson, MD, MPHS
      • Sub-Investigator: Taeho Kim, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who will be receiving standard of care radiation therapy approaches for tumors involving the chest wall (ribs, soft tissue, breast), thorax (lung, heart), or upper abdomen (liver, adrenal glands, pancreas, para-aortic lymph nodes) that requires motion management at Washington University School of Medicine.

Description

Eligibility Criteria

• Planning to receive a course of radiation therapy that, per the treating radiation oncologist, requires motion management at the time of CT simulation and during treatment. Types of treatments that require motion management during radiation therapy include treatments to the lung, heart, breast, and upper abdomen (pancreas, liver, adrenals). These may include either free-breathing treatments or breath-hold treatments.
• At least 18 years of age.
• No documented allergy to medical grade adhesives.
• Able to understand and willing to sign an IRB approved written informed consent document.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Motion management system during standard of care treatment; Patients will wear the motion management system (eMotus) during their CT simulation scan and each of their radiation therapy treatments (no more than 15 fractions). CT simulation will take approximately 40 minutes and radiation treatments will take approximately 15-45 minutes depending on the patient's plan. Patients will complete questionnaires collecting feedback on the device after receiving their last fraction of treatment.

Device: Patient Position Monitoring System; The device is a motion management system for patients receiving radiation therapy. The system is composed of a disposable fiber optic sensor pad, a signal transceiver, and software to receive and display patient data. The sensor pad is applied to the patient's chest or abdomen and plugged into the signal transceiver, which provides the system's software to provide a visual respiratory trace for the treatment team.; Other Names: EmpNia eMotus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of eMotus system as defined by frequency of successfully delivered treatment fraction	The feasibility of the eMotus fiber optic motion sensor system will be measured as the frequency of scheduled treatment fractions delivered successfully using eMotus. Success is defined as delivery of a treatment fraction in one on-table attempt without requiring the use of a secondary (backup) motion management system. Unsuccessful delivery of a treatment fraction will be defined as more than one attempt for gating without reproducible positioning, breath-hold, or surface guidance feedback such that the treatment could not be delivered with eMotus. Descriptive statistics will be collected and reported to determine the proportion of successful motion monitoring events.	Enrollment to completion of radiation therapy (estimated total time is 1 month)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: EmpNia
• Investigators: Principal Investigator: Pamela Samson, MD, 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): May 20, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Radiotherapy; Motion
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 202512129

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).
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal can email the Principal Investigator at psamson@wustl.edu. To go access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

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.: Yes