NCT04686500

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

Completed NA Results posted Last updated 25 November 2024

What this trial tests

NA trial testing Tidal volume measured by spirometer and DIBH surface from CT image in Thoracic Cancer in 10 participants. Completed in 21 June 2023.

Timeline

1 March 2019

Primary endpoint
20 July 2021

21 June 2023

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	10
Start date	1 March 2019
Primary completion	20 July 2021
Estimated completion	21 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Tidal volume measured by spirometer and DIBH surface from CT image

Conditions studied

• Thoracic Cancer — all drugs for Thoracic Cancer →
• Abdominal Cancer — all drugs for Abdominal Cancer →

Sponsor

University of Texas Southwestern Medical Center

Who can join

18 and older, any sex, with Thoracic Cancer or Abdominal Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Correlation Between Kilovoltages X-ray Images of the Diaphragm and the Surface Guided Motion Analyzed With Matlab Primary · 1 month

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

Vertical

Group	Value	95% CI
Deep Inspiration Breath-hold (DIBH) Respiratory Motion	0.01	-0.07 – 0.3

Longitudinal

Group	Value	95% CI
Deep Inspiration Breath-hold (DIBH) Respiratory Motion	0.07	-0.04 – 0.73

Target Margin Contingency Table Based on Surface and Diaphragm Motion Secondary · 1 month

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.

Bin [0 1)mm (Superior-Inferior Motion)

Group	Value	95% CI
Bin [0 1)mm kV	16172
Bin [1 2)mm kV	2161
Bin [2 3)mm kV	428
Bin [3 4)mm kV	92
Bin [4 5)mm kV	26
Bin [5 10)mm kV	14
Total kV	18893

Bin [1 2)mm (Superior-Inferior Motion)

Group	Value	95% CI
Bin [0 1)mm kV	3844
Bin [1 2)mm kV	741
Bin [2 3)mm kV	248
Bin [3 4)mm kV	50
Bin [4 5)mm kV	12
Bin [5 10)mm kV	7
Total kV	4902

Bin [2 3)mm (Superior-Inferior Motion)

Group	Value	95% CI
Bin [0 1)mm kV	1082
Bin [1 2)mm kV	257
Bin [2 3)mm kV	102
Bin [3 4)mm kV	26
Bin [4 5)mm kV	10
Bin [5 10)mm kV	9
Total kV	1486

Bin [3 4)mm (Superior-Inferior Motion)

Group	Value	95% CI
Bin [0 1)mm kV	506
Bin [1 2)mm kV	105
Bin [2 3)mm kV	24
Bin [3 4)mm kV	9
Bin [4 5)mm kV	4
Bin [5 10)mm kV	2
Total kV	650

Bin [4 5)mm (Superior-Inferior Motion)

Group	Value	95% CI
Bin [0 1)mm kV	216
Bin [1 2)mm kV	44
Bin [2 3)mm kV	11
Bin [3 4)mm kV	2
Bin [4 5)mm kV	1
Bin [5 10)mm kV	2
Total kV	276

Bin [5 10)mm (Superior-Inferior Motion)

Group	Value	95% CI
Bin [0 1)mm kV	304
Bin [1 2)mm kV	52
Bin [2 3)mm kV	13
Bin [3 4)mm kV	3
Bin [4 5)mm kV	0
Bin [5 10)mm kV	0
Total kV	372

Bin [10 15)mm (Superior-Inferior Motion)

Group	Value	95% CI
Bin [0 1)mm kV	19
Bin [1 2)mm kV	5
Bin [2 3)mm kV	3
Bin [3 4)mm kV	0
Bin [4 5)mm kV	0
Bin [5 10)mm kV	0
Total kV	27

Bin [15 20)mm (Superior-Inferior Motion)

Group	Value	95% CI
Bin [0 1)mm kV	0
Bin [1 2)mm kV	0
Bin [2 3)mm kV	0
Bin [3 4)mm kV	1
Bin [4 5)mm kV	0
Bin [5 10)mm kV	0
Total kV	1

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.