Evaluating a new imaging system for radiation therapy
A Prospective Imaging Study of Target Definition and Radiation Planning Workflows on the Integrated TrueBeam-HyperSight System for Patients Receiving Radiation Therapy
This study is testing a new imaging system to see if it can help improve radiation therapy for cancer patients by providing better images during treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Varian, a Siemens Healthineers Company Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05975619 on ClinicalTrials.gov |
What this trial studies
This study evaluates the integration of the HyperSight cone beam computed tomography (CBCT) imaging system with the TrueBeam radiotherapy system for patients undergoing radiation treatment for various cancers. The HyperSight system aims to improve image quality for tasks beyond patient alignment, such as anatomical contouring and radiation dose calculations. Patients scheduled for radiation therapy will have their images acquired prospectively, but their treatment will not be affected by participation. The study focuses on enhancing the imaging capabilities to potentially improve treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled to receive radiation therapy for head and neck, thoracic, abdominal, or pelvic cancers.
Not a fit: Patients who are unwilling to provide informed consent or are part of a vulnerable population may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved imaging quality, enhancing the precision of radiation therapy for cancer patients.
How similar studies have performed: While this approach is innovative, similar imaging advancements in radiation therapy have shown promise in enhancing treatment precision.
Eligibility criteria
Show full inclusion / exclusion 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").
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Sean Davidson
- Email: sean.davidson@varian.com
- Phone: 437-991-8294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.