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Completed

NCT Number: NCT04686500

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Target Margin Contingency Table Based on Surface and Diaphragm Motion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Vision RT Limited

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Dec 28, 2020
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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