Trial Outcomes & Findings for VisionRT-based Deep Inspiration Breath-hold (DIBH) Respiratory Motion Management Strategy, A Pilot Study for Thoracic and Abdominal Tumors (NCT NCT04686500)
NCT ID: NCT04686500
Last Updated: 2024-11-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
1 month
Results posted on
2024-11-25
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VisionRT-based Deep Inspiration Breath-hold (DIBH) Respiratory Motion Management Strategy, A Pilot Study for Thoracic and Abdominal Tumors
Baseline characteristics by cohort
| Measure |
Deep Inspiration Breath-hold (DIBH) Respiratory Motion
n=10 Participants
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.
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthVRT-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.
Outcome measures
| Measure |
Deep Inspiration Breath-hold (DIBH) Respiratory Motion
n=10 Participants
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.
|
Bin [1 2)mm kV
Contingency table motion range for kV
|
Bin [2 3)mm kV
Contingency table motion range for kV
|
Bin [3 4)mm kV
Contingency table motion range for kV
|
Bin [4 5)mm kV
Contingency table motion range for kV
|
Bin [5 10)mm kV
Contingency table motion range for kV
|
Total kV
Contingency table totals
|
|---|---|---|---|---|---|---|---|
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Correlation Between Kilovoltages X-ray Images of the Diaphragm and the Surface Guided Motion Analyzed With Matlab
Vertical
|
0.01 correlation coefficient
Interval -0.07 to 0.3
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—
|
—
|
—
|
—
|
—
|
—
|
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Correlation Between Kilovoltages X-ray Images of the Diaphragm and the Surface Guided Motion Analyzed With Matlab
Longitudinal
|
0.07 correlation coefficient
Interval -0.04 to 0.73
|
—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 1 monthPopulation: 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.
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.
Outcome measures
| Measure |
Deep Inspiration Breath-hold (DIBH) Respiratory Motion
n=10 Participants
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.
|
Bin [1 2)mm kV
n=10 Participants
Contingency table motion range for kV
|
Bin [2 3)mm kV
n=10 Participants
Contingency table motion range for kV
|
Bin [3 4)mm kV
n=10 Participants
Contingency table motion range for kV
|
Bin [4 5)mm kV
n=10 Participants
Contingency table motion range for kV
|
Bin [5 10)mm kV
n=10 Participants
Contingency table motion range for kV
|
Total kV
n=10 Participants
Contingency table totals
|
|---|---|---|---|---|---|---|---|
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Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [0 1)mm (Superior-Inferior Motion)
|
16172 sample points (number of movements)
|
2161 sample points (number of movements)
|
428 sample points (number of movements)
|
92 sample points (number of movements)
|
26 sample points (number of movements)
|
14 sample points (number of movements)
|
18893 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [1 2)mm (Superior-Inferior Motion)
|
3844 sample points (number of movements)
|
741 sample points (number of movements)
|
248 sample points (number of movements)
|
50 sample points (number of movements)
|
12 sample points (number of movements)
|
7 sample points (number of movements)
|
4902 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [2 3)mm (Superior-Inferior Motion)
|
1082 sample points (number of movements)
|
257 sample points (number of movements)
|
102 sample points (number of movements)
|
26 sample points (number of movements)
|
10 sample points (number of movements)
|
9 sample points (number of movements)
|
1486 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [3 4)mm (Superior-Inferior Motion)
|
506 sample points (number of movements)
|
105 sample points (number of movements)
|
24 sample points (number of movements)
|
9 sample points (number of movements)
|
4 sample points (number of movements)
|
2 sample points (number of movements)
|
650 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [4 5)mm (Superior-Inferior Motion)
|
216 sample points (number of movements)
|
44 sample points (number of movements)
|
11 sample points (number of movements)
|
2 sample points (number of movements)
|
1 sample points (number of movements)
|
2 sample points (number of movements)
|
276 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [5 10)mm (Superior-Inferior Motion)
|
304 sample points (number of movements)
|
52 sample points (number of movements)
|
13 sample points (number of movements)
|
3 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
372 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [10 15)mm (Superior-Inferior Motion)
|
19 sample points (number of movements)
|
5 sample points (number of movements)
|
3 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
27 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [15 20)mm (Superior-Inferior Motion)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
1 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
1 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Total (Superior-Inferior Motion)
|
22143 sample points (number of movements)
|
3365 sample points (number of movements)
|
829 sample points (number of movements)
|
183 sample points (number of movements)
|
53 sample points (number of movements)
|
34 sample points (number of movements)
|
26607 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [0 1)mm (Anterior-Posterior Motion)
|
19344 sample points (number of movements)
|
2846 sample points (number of movements)
|
711 sample points (number of movements)
|
157 sample points (number of movements)
|
48 sample points (number of movements)
|
28 sample points (number of movements)
|
23134 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [1 2)mm (Anterior-Posterior Motion)
|
1798 sample points (number of movements)
|
288 sample points (number of movements)
|
59 sample points (number of movements)
|
21 sample points (number of movements)
|
4 sample points (number of movements)
|
3 sample points (number of movements)
|
2173 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [2 3)mm (Anterior-Posterior Motion)
|
493 sample points (number of movements)
|
106 sample points (number of movements)
|
18 sample points (number of movements)
|
5 sample points (number of movements)
|
1 sample points (number of movements)
|
3 sample points (number of movements)
|
626 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [3 4)mm (Anterior-Posterior Motion)
|
181 sample points (number of movements)
|
38 sample points (number of movements)
|
7 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
226 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [4 5)mm (Anterior-Posterior Motion)
|
97 sample points (number of movements)
|
21 sample points (number of movements)
|
3 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
121 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [5 10)mm (Anterior-Posterior Motion)
|
192 sample points (number of movements)
|
54 sample points (number of movements)
|
28 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
274 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Bin [10 15)mm (Anterior-Posterior Motion)
|
38 sample points (number of movements)
|
12 sample points (number of movements)
|
3 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
0 sample points (number of movements)
|
53 sample points (number of movements)
|
|
Target Margin Contingency Table Based on Surface and Diaphragm Motion
Total (Anterior-Posterior Motion)
|
22143 sample points (number of movements)
|
3365 sample points (number of movements)
|
829 sample points (number of movements)
|
183 sample points (number of movements)
|
53 sample points (number of movements)
|
34 sample points (number of movements)
|
26607 sample points (number of movements)
|
Adverse Events
Deep Inspiration Breath-hold (DIBH) Respiratory Motion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Parsons
University of Texas Southwestern Medical Center
Phone: 214/645-8525
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place