RadiotherapyNCT07373496
Patient Position Monitoring System for Beam Gated Radiation Therapy of Malignancies of the Chest and Upper Abdomen
An observational study of Radiotherapy and Radiotherapy, Image-Guided, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy, Radiotherapy, Image-Guided
- What is being tested?
- Patient Position Monitoring System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Pamela Samson, MD, MPHS, 314-801-3806, psamson@wustl.edu
Pamela Samson, MD, MPHS
About this study
Official title: 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.
- Conditions
- Radiotherapy, Radiotherapy, Image-Guided
- Being tested
- Patient Position Monitoring System
- Keywords
- Radiotherapy, Cancer, Motion
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Position Monitoring SystemDevice
Also called EmpNia eMotus
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Patient Position Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment to completion of radiation therapy (estimated total time is 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start20 May 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- EmpNia
- Responsible party
- Sponsor
- Investigators
- Pamela Samson, MD, MPHS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373496
- Sponsor's protocol ID
- 202512129
- Status last verified
- May 2026
- First submitted
- 20 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Novel Patient Position Monitoring System for Beam Gated Radiation Therapy of Malignancies of the Chest and Upper Abdomen
- ClinicalTrials.gov ID
- NCT07373496
- Acronym / sponsor ID
- 202512129
- Conditions
- Radiotherapy, Radiotherapy, Image-Guided
- Keywords
- Radiotherapy, Cancer, Motion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- EmpNia
- Study start
- 20 May 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motion management system during standard of care treatment | – | Device: Patient Position Monitoring SystemPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Position Monitoring SystemAlso: EmpNia eMotusThe 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. | Device | Motion management system during standard of care treatment |
Primary outcome
Feasibility of eMotus system as defined by frequency of successfully delivered treatment fraction
Time frame: Enrollment to completion of radiation therapy (estimated total time is 1 month)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pamela Samson, MD, MPHS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiotherapy and Radiotherapy, Image-Guided, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Samson, MD, MPHS (314-801-3806, psamson@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of eMotus system as defined by frequency of successfully delivered treatment fraction (time frame: Enrollment to completion of radiation therapy (estimated total time is 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.