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Trial Title:
A Prospective Imaging Study of the Integrated TrueBeam-HyperSight CBCT System
NCT ID:
NCT05975619
Condition:
Head and Neck Cancer
Thoracic Cancer
Abdominal Cancer
Pelvic Cancer
Conditions: Official terms:
Pelvic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
HyperSight imaging
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.
Arm group label:
HyperSight Imaging arm
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.
Criteria for 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").
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals Cleveland Medical Center
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lauren Henke, MD
Phone:
800-641-2422
Email:
CTUReferral@UHhospitals.org
Investigator:
Last name:
Lauren Henke, MD
Email:
Principal Investigator
Start date:
August 29, 2023
Completion date:
January 2025
Lead sponsor:
Agency:
Varian, a Siemens Healthineers Company
Agency class:
Industry
Source:
Varian, a Siemens Healthineers Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05975619
