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

Launched by VARIAN, A SIEMENS HEALTHINEERS COMPANY · Jul 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technology called the HyperSight system, which is designed to improve the quality of images used during radiation treatment for various types of cancer, including head and neck, thoracic, abdominal, and pelvic cancers. The goal is to see how well this new system works when combined with an existing radiation treatment machine called the TrueBeam. Participants will have images taken as part of their regular treatment, but their actual radiation therapy will not change. This means that joining the study will not affect how they receive their care.

To be eligible for the trial, participants must be at least 18 years old and scheduled to receive radiation therapy for one of the specified cancer sites. They should also have good kidney function if they will receive a specific type of imaging that uses a contrast dye. Women who can become pregnant must have a negative pregnancy test before joining. Participants can expect to undergo standard imaging as part of their treatment, and the study will evaluate the quality of the new images compared to the older methods. It’s important to note that individuals who cannot fully understand the study or who feel pressured to participate are not eligible.

Gender

ALL

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").