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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Motion management system during standard of care treatment1 intervention

Trial outcomes

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.

Time frame
Enrollment to completion of radiation therapy (estimated total time is 1 month)

Secondary outcomes

Other outcomes

Sponsors and contacts

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