Clinical trial NCT05975619: A Prospective Imaging Study of the Integrated TrueBeam-HyperSight CBCT System
Official title: A Prospective Imaging Study of Target Definition and Radiation Planning Workflows on the Integrated TrueBeam-HyperSight System for Patients Receiving Radiation Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Thoracic Cancer
Abdominal Cancer
Pelvic Cancer
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2023-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, single-arm, single-site feasibility study designed to generate data describing the quality and applicability of on-couch high-performance CBCT imaging technology.
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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").

Primary outcomes:
measure: Feasibility of using HyperSight CBCT images for radiation treatment planning.
timeFrame: 1-9 weeks
Secondary outcomes:
Other outcomes:
measure: OAR delineation
timeFrame: 1-9 weeks
measure: Image quality - quantitative
timeFrame: 1-9 weeks
measure: Image quality - qualitative
timeFrame: 1-9 weeks
measure: Patient anxiety
timeFrame: 1-9 weeks
measure: Treatment plan quality
timeFrame: 1-9 weeks
measure: Patient clearance
timeFrame: 1-9 weeks
measure: Timing of image registration
timeFrame: 1-9 weeks
measure: Confidence in image registration
timeFrame: 1-9 weeks
measure: Impact of off-axis imaging on Hounsfield Unit accuracy
timeFrame: 1-9 weeks
measure: Impact of image acquisition time on clinical efficiency
timeFrame: 1-9 weeks
measure: Feasibility of obtaining respiratory gated HyperSight CBCT
timeFrame: 1-9 weeks
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
References: