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

NCT07373496 | Recruiting FDA Device

• 1 other identifier: 202512129
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiotherapy; Radiotherapy, Image-Guided

Keywords

Radiotherapy; Cancer; Motion

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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

Interventions

Patient Position Monitoring System DEVICE

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.

Also known as: EmpNia eMotus

Motion management system during standard of care treatment

Eligibility Criteria

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

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• EmpNia: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Neoplasms

Study Officials

• Pamela Samson, MD, MPHS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Samson, MD, MPHS

CONTACT

314-801-3806; psamson@wustl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• 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.

Locations

US (1)