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

NCT04686500 | Completed Results DMC

• 1 other identifier: 022017-075
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Cancer; Abdominal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Target Margin Contingency Table Based on Surface and Diaphragm Motion

  1 month

Study Arms (1)

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

Device: Tidal volume measured by spirometer and DIBH surface from CT image

Interventions

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.

Deep Inspiration Breath-hold (DIBH) Respiratory Motion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).
• Patients must be compliant to all required pretreatment evaluations

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Vision RT Limited: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Results Point of Contact

• Title: Dr. David Parsons
• Organization: University of Texas Southwestern Medical Center

david.parsons@utsouthwestern.edu

214/645-8525

Study Officials

• David Parsons, PHD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR, Radiation Oncology - RO-Medical Physics&Engineering

Model Details: Prospective study with retrospective data analysis

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 28, 2020
• Study Start: March 1, 2019
• Primary Completion: July 20, 2021
• Study Completion: June 21, 2023
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-10

Locations

US (1)