Back to resultsVisionRT-based Deep Inspiration Breath-hold (DIBH) Respiratory Motion Management Strategy, A Pilot Study for Thoracic and Abdominal Tumors
Primary Purpose
Thoracic Cancer, Abdominal Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tidal volume measured by spirometer and DIBH surface from CT image
Sponsored by
About this trial
This is an interventional device feasibility trial for Thoracic Cancer
Eligibility Criteria
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
Sites / Locations
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Deep Inspiration Breath-hold (DIBH) Respiratory Motion
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04686500
First Posted
November 30, 2020
Last Updated
May 5, 2022
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Vision RT Limited
1. Study Identification
Unique Protocol Identification Number
NCT04686500
Brief Title
VisionRT-based Deep Inspiration Breath-hold (DIBH) Respiratory Motion Management Strategy, A Pilot Study for Thoracic and Abdominal Tumors
Official Title
VisionRT-based Deep Inspiration Breath-hold (DIBH) Respiratory Motion Management Strategy, A Pilot Study for Thoracic and Abdominal Tumors Stereotactic Body Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Vision RT Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Cancer, Abdominal Cancer
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective study with retrospective data analysis
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deep Inspiration Breath-hold (DIBH) Respiratory Motion
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Tidal volume measured by spirometer and DIBH surface from CT image
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
To determine planning target volume margin by investigating tumor residual motion in VRT-DIBH (Vision Radiation Therapy- Deep Inspiration Breath-hold).
Description
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.
Time Frame
1 month
Title
To determine Vision Radiation Therapy (VRT) surface monitoring threshold
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Parsons, PHD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Learn more about this trial
VisionRT-based Deep Inspiration Breath-hold (DIBH) Respiratory Motion Management Strategy, A Pilot Study for Thoracic and Abdominal Tumors
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