Evaluating new imaging technology for cancer radiation therapy
A Feasibility Study of a Novel Cone-Beam CT Approach for Image Guided Radiotherapy in Cancer Patients
This study is testing a new imaging technology for cancer radiation therapy to see if it can provide better pictures than the standard method, helping patients get more effective treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Varian, a Siemens Healthineers Company Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 4 sites (Columbus, Ohio and 3 other locations) |
| Trial ID | NCT06681233 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of a new imaging technology called HyperSight, developed by Varian Medical Systems, for use in radiation therapy for various cancers. HyperSight is designed to improve image quality compared to conventional cone beam computed tomography (CBCT), which is commonly used for patient alignment during treatment. The study will compare the imaging capabilities of HyperSight CBCT with traditional CBCT to determine its effectiveness in enhancing the radiation therapy workflow. Patients receiving radiation therapy for specific malignancies will be included in the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing radiation therapy for head and neck, thoracic, liver, breast, genitourinary, or gastrointestinal cancers.
Not a fit: Patients with a poor performance status, limited life expectancy, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology 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, it builds on existing imaging technologies, and similar studies have shown promise in improving imaging quality in radiation therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient age ≥ 18 2. Patient is receiving radiation therapy for head and neck, thorax, liver, breast, genitourinary, or gastrointestinal malignancies 3. A CBCT acquisition for localization is standard of care for the radiation therapy treatment plan being delivered Exclusion Criteria: 1. Patient has ECOG Performance Status ≥3. 2. Patient is wheelchair bound. 3. Patient has a life expectancy \<3 months. 4. Patient is unwilling or unable to provide informed consent to participate in the study. 5. Patient is pregnant or has plans for pregnancy during the period of treatment. 6. 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"). This includes prisoners.
Where this trial is running
Columbus, Ohio and 3 other locations
- James Outpatient Center — Columbus, Ohio, United States (Recruiting)
- Ohio State University, Brain and Spine Hospital — Columbus, Ohio, United States (Recruiting)
- The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute — Columbus, Ohio, United States (Recruiting)
- Stefanie Spielman Comprehensive Breast Center — Columbus, 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.