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| Name | Class |
|---|---|
| Vision RT Limited | INDUSTRY |
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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.
VRT-DIBH has already applied to left breast radiotherapy to spare lung and heart. Compared to ABC-DIBH, VRT-DIBH has several potential advantages:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Inspiration Breath-hold (DIBH) Respiratory Motion | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tidal volume measured by spirometer and DIBH surface from CT image | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Kilovoltages X-ray Images of the Diaphragm and the Surface Guided Motion Analyzed With Matlab | 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 kV projections and VRT surface images, will be taken and analyzed for this purpose. The trajectory data and kV projection data were analyzed in Matlab. In the kV images, the diaphragm was segmented and used for tracking of the BH position. This was done using several steps including: derivatives, polynomial curve fitting and high pass filtering. The correlation was then measured using a Pearson correlation. Correlation of each breath hold was taken and averaged. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Target Margin Contingency Table Based on Surface and Diaphragm Motion | To assess the necessary margin for a target, the amount of surface and diaphragm motion was analyzed. For each x-ray image the diaphragm motion and corresponding surface motion were recorded. These motions were then categorized based on their size and researchers counted how often these movements fell within the specified motion ranges. |
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Inclusion Criteria:
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:
3.2 Patients must be compliant to all required pretreatment evaluations
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Parsons, PHD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Deep Inspiration Breath-hold (DIBH) Respiratory Motion | 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 Tidal volume measured by spirometer and DIBH surface from CT image: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2021 |
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Prospective study with retrospective data analysis
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| 1 month |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Deep Inspiration Breath-hold (DIBH) Respiratory Motion | 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 Tidal volume measured by spirometer and DIBH surface from CT image: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation Between Kilovoltages X-ray Images of the Diaphragm and the Surface Guided Motion Analyzed With Matlab | 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 kV projections and VRT surface images, will be taken and analyzed for this purpose. The trajectory data and kV projection data were analyzed in Matlab. In the kV images, the diaphragm was segmented and used for tracking of the BH position. This was done using several steps including: derivatives, polynomial curve fitting and high pass filtering. The correlation was then measured using a Pearson correlation. Correlation of each breath hold was taken and averaged. | Posted | Mean | Full Range | correlation coefficient | 1 month |
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| Secondary | Target Margin Contingency Table Based on Surface and Diaphragm Motion | To assess the necessary margin for a target, the amount of surface and diaphragm motion was analyzed. For each x-ray image the diaphragm motion and corresponding surface motion were recorded. These motions were then categorized based on their size and researchers counted how often these movements fell within the specified motion ranges. | Outcomes for secondary objectives have been combined in this contingency table between motion range of kV and motion of superior-inferior and anterior-posterior surfaces. | Posted | Number | sample points (number of movements) | 1 month |
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AEs were not collected for this trial
AEs were not collected for this trial
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deep Inspiration Breath-hold (DIBH) Respiratory Motion | 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 Tidal volume measured by spirometer and DIBH surface from CT image: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Parsons | University of Texas Southwestern Medical Center | 214/645-8525 | david.parsons@utsouthwestern.edu |
| Jul 26, 2022 |
| Prot_SAP_000.pdf |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG004 | Bin [4 5)mm kV | Contingency table motion range for kV |
| OG005 | Bin [5 10)mm kV | Contingency table motion range for kV |
| OG006 | Total kV | Contingency table totals |
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