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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Thoracic Cancer; Abdominal Cancer
• Intervention / Treatment: Device: Tidal volume measured by spirometer and DIBH surface from CT image

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: 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

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the feasibility of applying VRT-DIBH (Vision Radiation Therapy- Deep Inspiration Breath-hold) to lung/liver cancer SBRT(Stereotactic Body Radiotherapy Treatment) using descriptive statistics.	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 CBCT (cone-beam computed tomography) and VRT surface images, will be taken and analyzed for this purpose. All recorded CBCT images will be used for tumor and critical organs geometry accuracy study by exporting to Velocity software.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine planning target volume margin by investigating tumor residual motion in VRT-DIBH (Vision Radiation Therapy- Deep Inspiration Breath-hold).	On the acquired four different DIBH CTs, gross tumor volume (GTV) will be contoured by an appropriately trained physician. Tumor center point (center of mass) will be the identified and used for motion evaluation. Both inter- and intra- motion amplitude will be analyzed and margins will be estimated. The acquired high-resolution DIBH CT will be used as a primary image for planning. Physician will expand the GTV (gross tumor volume) to PTV (planning target volume) by adding proper size margins.	1 month
To determine Vision Radiation Therapy (VRT) surface monitoring threshold	To determine VRT surface monitoring threshold (in mm) in which (DIBH) Deep Inspiration Breath-hold determines how much surface motion is allowable until the target is outside the PTV (planning target volume) expansion.	1 month

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Vision RT Limited
• Investigators: Principal Investigator: David Parsons, PHD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): July 20, 2021
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (ACTUAL): December 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Abdominal Neoplasms
• Other Study ID Numbers: 022017-075

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No