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

Not Applicable

Completed

• Conditions: Abdominal Cancer; Thoracic Cancer
• Interventions: Device: Tidal volume measured by spirometer and DIBH surface from CT image

• Registration Number: NCT04686500
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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

VRT-DIBH has already applied to left breast radiotherapy to spare lung and heart. Compared to ABC-DIBH, VRT-DIBH has several potential advantages:

1. 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;

2. VRT is more cost effective, as patient tubing needs to be replaced daily for ABC;

3. 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.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-28
• Primary Completion: 2021-07-20
• Results First Submitted: 2022-07-26
• Study Completion: 2023-06-21
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Results First Posted: 2024-11-25
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients must be willing and capable to provide informed consent to participate in the protocol.
2. Patient with presumed pulmonary function capable of holding breath for at least 30 seconds - later to be confirmed.
3. 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

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Exclusion Criteria

1. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus
2. Patients are not compliant to all required pretreatment evaluations

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deep Inspiration Breath-hold (DIBH) Respiratory Motion	Tidal volume measured by spirometer and DIBH surface from CT image	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

Primary Outcome Measures

Name	Time	Method
Correlation Between Kilovoltages X-ray Images of the Diaphragm and the Surface Guided Motion Analyzed With Matlab	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 and high pass filtering. The correlation was then measured using a Pearson correlation. Correlation of each breath hold was taken and averaged.

Secondary Outcome Measures

Name	Time	Method
Target Margin Contingency Table Based on Surface and Diaphragm Motion	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.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States