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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Head and Neck Cancer; Thoracic Cancer; Abdominal Cancer; Pelvic Cancer
• Intervention / Treatment: Device: HyperSight imaging

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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").

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HyperSight Imaging arm; Subjects are imaged with the new HyperSight CBCT imaging system.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Image quality - quantitative	Assessed through calculated image metrics.	1-9 weeks
Image quality - qualitative	Assessed through expert observer evaluations of the images for utility in the radiotherapy workflow.	1-9 weeks
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
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
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
Timing of image registration	The time required to register a HyperSight CBCT to the patient's reference CT simulation image.	1-9 weeks
Confidence in image registration	Assessed through a user-rated confidence (measured using a three-point scale: low/moderate/high).	1-9 weeks
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
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
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

Collaborators and Investigators

• Sponsor: Varian, a Siemens Healthineers Company

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2023
• Primary Completion (Actual): March 24, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Pelvic Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: VAR-2023-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes