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

Primary Purpose

Head and Neck Cancer, Thoracic Cancer, Abdominal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HyperSight imaging
Sponsored by
Varian, a Siemens Healthineers Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient is scheduled to receive radiation therapy to one of the following anatomical sites: head and neck/brain, thorax, abdomen, pelvis. Patient is at least 18 years of age. 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. 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: Patient is unwilling or unable to sign an IRB-approved written informed consent document. 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").

Sites / Locations

  • University Hospitals Cleveland Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HyperSight Imaging arm

Arm Description

Subjects are imaged with the new HyperSight CBCT imaging system.

Outcomes

Primary Outcome Measures

Feasibility of using HyperSight CBCT images for radiation treatment planning.
The percentage of images that are of sufficient quality for patient treatment plan generation.

Secondary Outcome Measures

Full Information

First Posted
July 17, 2023
Last Updated
September 5, 2023
Sponsor
Varian, a Siemens Healthineers Company
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1. Study Identification

Unique Protocol Identification Number
NCT05975619
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 29, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Varian, a Siemens Healthineers Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Thoracic Cancer, Abdominal Cancer, Pelvic Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HyperSight Imaging arm
Arm Type
Experimental
Arm Description
Subjects are imaged with the new HyperSight CBCT imaging system.
Intervention Type
Device
Intervention Name(s)
HyperSight imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of using HyperSight CBCT images for radiation treatment planning.
Description
The percentage of images that are of sufficient quality for patient treatment plan generation.
Time Frame
1-9 weeks
Other Pre-specified Outcome Measures:
Title
OAR delineation
Description
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.
Time Frame
1-9 weeks
Title
Image quality - quantitative
Description
Assessed through calculated image metrics.
Time Frame
1-9 weeks
Title
Image quality - qualitative
Description
Assessed through expert observer evaluations of the images for utility in the radiotherapy workflow.
Time Frame
1-9 weeks
Title
Patient anxiety
Description
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".
Time Frame
1-9 weeks
Title
Treatment plan quality
Description
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.
Time Frame
1-9 weeks
Title
Patient clearance
Description
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.
Time Frame
1-9 weeks
Title
Timing of image registration
Description
The time required to register a HyperSight CBCT to the patient's reference CT simulation image.
Time Frame
1-9 weeks
Title
Confidence in image registration
Description
Assessed through a user-rated confidence (measured using a three-point scale: low/moderate/high).
Time Frame
1-9 weeks
Title
Impact of off-axis imaging on Hounsfield Unit accuracy
Description
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.
Time Frame
1-9 weeks
Title
Impact of image acquisition time on clinical efficiency
Description
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.
Time Frame
1-9 weeks
Title
Feasibility of obtaining respiratory gated HyperSight CBCT
Description
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.
Time Frame
1-9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is scheduled to receive radiation therapy to one of the following anatomical sites: head and neck/brain, thorax, abdomen, pelvis. Patient is at least 18 years of age. 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. 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: Patient is unwilling or unable to sign an IRB-approved written informed consent document. 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").
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Davidson
Phone
437-991-8294
Email
sean.davidson@varian.com
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Henke, MD
Phone
800-641-2422
Email
CTUReferral@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Lauren Henke, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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