Status:
ACTIVE_NOT_RECRUITING
A Prospective Imaging Study of the Integrated TrueBeam-HyperSight CBCT System
Lead Sponsor:
Varian, a Siemens Healthineers Company
Conditions:
Head and Neck Cancer
Thoracic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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
- 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").
Key Trial Info
Start Date :
August 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05975619
Start Date
August 29 2023
End Date
April 1 2026
Last Update
June 24 2025
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106