VisionRT-based Deep Inspiration Breath-hold (DIBH) Respiratory Motion Management Strategy, A Pilot Study for Thoracic and Abdominal Tumors

Study Overview
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Brief Summary
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A more recent competing technology for implementing the DIBH technique is real-time surface photogrammetry using the AlignRT system (Vision RT Ltd., London, UK). AlignRT system use non-ionization near infrared light to track patient surface motion. The system has one projector projecting near infrared optical pattern on patient surface. The optical pattern is imaged by optical cameras (two per pod) at  25 Hz. The user selects a region-of-interest (ROI) on the surface and the software calculates and displays the real-time position in six degrees (3 translations and 3 rotations) in real-time. Once the patient has matched the pre-determined DIBH position (within threshold accuracy), the radiation beam is enabled to be turned on for treatment.

Detailed Description
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VRT-DIBH has already applied to left breast radiotherapy to spare lung and heart. Compared to ABC-DIBH, VRT-DIBH has several potential advantages: VRT monitors patient (surface) position in addition to DIBH signal, while ABC only check the tidal volume, which can remain the same even if the patient shifts slightly on the couch; VRT is more cost effective, as patient tubing needs to be replaced daily for ABC; VRT potentially has advantage on patient compliance, as with ABC breath is forced impeded while with VRT breath-hold is voluntary. In this study, we renovate the established DIBH motion management strategy by adopting AlignRT system. The purpose of this study is to develop, validate, and prove the feasibility of VRT-DIBH technique for lung and liver SBRT.

Official Title
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VisionRT-based Deep Inspiration Breath-hold (DIBH) Respiratory Motion Management Strategy, A Pilot Study for Thoracic and Abdominal Tumors Stereotactic Body Radiotherapy

Conditions
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Thoracic Cancer, Abdominal Cancer

Intervention / Treatment
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* Device: Tidal volume measured by spirometer and DIBH surface from CT image


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be willing and capable to provide informed consent to participate in the protocol. Patient with presumed pulmonary function capable of holding breath for at least 30 seconds - later to be confirmed. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and until study imaging is complete. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 3.1 A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 3.2 Patients must be compliant to all required pretreatment evaluations Exclusion Criteria: Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus Patients are not compliant to all required pretreatment evaluations

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective study with retrospective data analysis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Deep Inspiration Breath-hold (DIBH) Respiratory Motion<br>DIBH qualified patient will experience one high-resolution CT scan as SOC and additional 3 low resolution/lower dose CT scans to further investigate inter-DIBH patient surface and tumor position stability and repeatability | Device: Tidal volume measured by spirometer and DIBH surface from CT image<br>* The SOC DIBH CT scan will be transferred to Eclipse treatment planning system for treatment planning. Tidal volume measured by spirometer and DIBH surface from CT image will be used as a reference surface for patient treatment initial setup. CBCT will be acquired before each fractional treatment for the patient alignment before beam delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the feasibility of applying VRT-DIBH (Vision Radiation Therapy- Deep Inspiration Breath-hold) to lung/liver cancer SBRT(Stereotactic Body Radiotherapy Treatment) using descriptive statistics. | VRT-DIBH (VisionRT-based deep inspiration breath-hold) feasibility will be evaluated using descriptive statistics to explore the geometry accuracy and to characterize tumor motion/surface stability and repeatability during treatment. CT images of the treatment site, as well as CBCT (cone-beam computed tomography) and VRT surface images, will be taken and analyzed for this purpose. All recorded CBCT images will be used for tumor and critical organs geometry accuracy study by exporting to Velocity software. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine planning target volume margin by investigating tumor residual motion in VRT-DIBH (Vision Radiation Therapy- Deep Inspiration Breath-hold). | On the acquired four different DIBH CTs, gross tumor volume (GTV) will be contoured by an appropriately trained physician. Tumor center point (center of mass) will be the identified and used for motion evaluation. Both inter- and intra- motion amplitude will be analyzed and margins will be estimated. The acquired high-resolution DIBH CT will be used as a primary image for planning. Physician will expand the GTV (gross tumor volume) to PTV (planning target volume) by adding proper size margins. | 1 month | 
| To determine Vision Radiation Therapy (VRT) surface monitoring threshold | To determine VRT surface monitoring threshold (in mm) in which (DIBH) Deep Inspiration Breath-hold determines how much surface motion is allowable until the target is outside the PTV (planning target volume) expansion. | 1 month |