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

Thoracic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04686500
• Other study ID #: 022017-075
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2022
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 1, 2022
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Cancer
• Abdominal Neoplasms
• Thoracic Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Vision RT Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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