A Prospective Imaging Study of the Integrated TrueBeam-HyperSight CBCT System

Head and Neck Cancer Clinical Trial

Official title:

A Prospective Imaging Study of Target Definition and Radiation Planning Workflows on the Integrated TrueBeam-HyperSight System for Patients Receiving Radiation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05975619
• Other study ID #: VAR-2023-03
• Status: Recruiting
• Phase: N/A
• Start date: August 29, 2023
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: Varian, a Siemens Healthineers Company
• Contact: Sean Davidson
• Phone: 437-991-8294
• Email: sean.davidson[@]varian.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cone beam computed tomography (CBCT) images are routinely used in radiation treatment delivery workflows to align patients with the treatment beam. Conventional CBCT image quality is sufficient for this task but not good enough for other radiotherapy-related tasks, such as contouring anatomical structures and calculating radiation dose distributions. HyperSight is a new CBCT imaging system manufactured by Varian Medical Systems. The purpose of this study is to evaluate the integration of the HyperSight imaging system with Varian's TrueBeam radiotherapy system, a linear accelerator with a C-arm gantry that rotates about the patient to delivery radiation to the target malignancy. HyperSight CBCT images will be acquired prospectively from patients who are receiving radiation treatment. The HyperSight/TrueBeam system will be used for imaging only; patients receive their radiation treatment on cleared devices and no aspect of their treatment is affected by participation in the study. HyperSight images collected during the study will be evaluated for quality and utility and compared to conventional CBCT images as well as fan beam CT images used for treatment planning.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is scheduled to receive radiation therapy to one of the following anatomical sites: head and neck/brain, thorax, abdomen, pelvis.

2. Patient is at least 18 years of age.

3. If the patient will be receiving IV contrast on study, patient must have adequate renal function as defined by an estimated glomerular filtration rate (eGFR) of >30.

Note: if no IV contrast will be administered on study, patient may enroll without creatinine level documented. Contrast eligibility will be determined as per Appendix A.

4. If the patient is a woman of childbearing potential, patient must have a negative pregnancy test within 30 days of enrollment and prior to any study imaging. Contraceptive use is not an adequate documentation of no chance of pregnancy.

Exclusion Criteria:

1. Patient is unwilling or unable to sign an IRB-approved written informed consent document.

2. Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response").

Related Conditions & MeSH terms

• Abdominal Cancer
• Head and Neck Cancer
• Pelvic Cancer
• Pelvic Neoplasms
• Thoracic Cancer

Intervention

Device:
• HyperSight imaging
Subjects are scheduled for 1 to 5 HyperSight imaging sessions, which will occur on the same days as their standard clinical visits during planning and treatment delivery. A total of 5 to 10 HyperSight CBCT images will be acquired over all imaging sessions.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Varian, a Siemens Healthineers Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	OAR delineation	Comparison of organ at risk (OAR) delineation on TrueBeam-HyperSight CBCT images to OAR delineation on conventional CBCT images, as well as on fan beam CT.	1-9 weeks
Other	Image quality - quantitative	Assessed through calculated image metrics.	1-9 weeks
Other	Image quality - qualitative	Assessed through expert observer evaluations of the images for utility in the radiotherapy workflow.	1-9 weeks
Other	Patient anxiety	Assessed through a patient survey using the validated Six-Item State Anxiety Scale derived from the State-Trait Anxiety Inventory. Each of the six items in the survey are assigned a score from 1 to 4 indicating the patient's agreement to a statement such as "I am tense", where 1 represents "Not at all", and 4 represents "Very much so".	1-9 weeks
Other	Treatment plan quality	Assessed through comparison of dose-volume histogram (DVH) metrics extracted from the re-calculation of the patient's treatment plan on the HyperSight CBCT to DVH metrics from the patient's treatment plan originally calculated on the pre-treatment simulation fan-beam CT.	1-9 weeks
Other	Patient clearance	Evaluated by the number of instances where patient positioning and/or custom immobilization devices created for their standard-of-care radiation therapy were incompatible with system geometries of the TrueBeam-HyperSight system during imaging and clearance checks.	1-9 weeks
Other	Timing of image registration	The time required to register a HyperSight CBCT to the patient's reference CT simulation image.	1-9 weeks
Other	Confidence in image registration	Assessed through a user-rated confidence (measured using a three-point scale: low/moderate/high).	1-9 weeks
Other	Impact of off-axis imaging on Hounsfield Unit accuracy	In images where the center of rotation is shifted, the impact of the off-axis imaging on the HU accuracy will be evaluated by comparing dose-volume histogram metrics between the treatment plan generated on the off-axis HyperSight CBCT and DVH metrics from the patient's treatment plan, calculated on a fan-beam CT that does not have the same limited field of view as the CBCT.	1-9 weeks
Other	Impact of image acquisition time on clinical efficiency	Timing of workflow steps and processes including setup, imaging, alignment, and door-to-door time as compared to standard-of-care imaging processes, and compared to clinical models for hypothetical, generic clinics, using a time-driven, activity-based cost model.	1-9 weeks
Other	Feasibility of obtaining respiratory gated HyperSight CBCT	Assessed through evaluation of internal motion volumes of organs-at-risk and targets, relative to diaphragm and/or vertebral body position, as compared to 4D-CT from standard-of-care simulation imaging.	1-9 weeks
Primary	Feasibility of using HyperSight CBCT images for radiation treatment planning.	The percentage of images that are of sufficient quality for patient treatment plan generation.	1-9 weeks