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

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04686500
Collaborator
Vision RT Limited (Other)
10
1
1
45
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Tidal volume measured by spirometer and DIBH surface from CT image
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective study with retrospective data analysisProspective study with retrospective data analysis
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
VisionRT-based Deep Inspiration Breath-hold (DIBH) Respiratory Motion Management Strategy, A Pilot Study for Thoracic and Abdominal Tumors Stereotactic Body Radiotherapy
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Jul 20, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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. [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 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

  1. To determine planning target volume margin by investigating tumor residual motion in VRT-DIBH (Vision Radiation Therapy- Deep Inspiration Breath-hold). [1 month]

    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.

  2. To determine Vision Radiation Therapy (VRT) surface monitoring threshold [1 month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UT Southwestern Medical Center Dallas Texas United States 75390

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center
  • Vision RT Limited

Investigators

  • Principal Investigator: David Parsons, PHD, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Parsons, PhD, ASSISTANT PROFESSOR, Radiation Oncology - RO-Medical Physics&Engineering, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT04686500
Other Study ID Numbers:
  • 022017-075
First Posted:
Dec 28, 2020
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2022