Head and Neck CancerBreast CancerUpper Gastrointestinal CancerLung CancerPelvic Cancer
Investigational drug(s) / intervention(s)
HyperSight Imaging
HyperSight Imaging: Patients receive standard of care radiation treatment on a Varian TrueBeam system equipped with HyperSight CBCT imaging. Images acquired for daily patient positioning from two different treatment fractions - typically one near the beginning of the treatment course and one at about the halfway point - will be analyzed for the study.
Study summary
The primary objective of radiation therapy is to deliver a therapeutic dose of radiation precisely to the target while minimizing exposure to healthy surrounding tissues. Image-guided radiation therapy (IGRT) involves acquiring cone beam computed tomography (CBCT) scans just before or during treatment sessions. By comparing the CBCT images with the reference images from the treatment planning process, clinicians can make necessary adjustments to ensure precise targeting and account for any changes that may have occurred since the initial planning. Conventional CBCT technology is, however, limited by several factors including long acquisition times that result in motion artifacts in the image, smaller fields of view that limit the volume of anatomy that can be imaged, poor image quality that limits soft tissue visibility, and artifacts created by dense metal implants. This study will evaluate a novel CBCT imaging solution ("HyperSight") that has the potential to address the challenges of conventional CBCT.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patient is willing and able to provide written consent.
2. Patient is at least 18 years of age at the time of consent.
3. Patient has biopsy confirmed malignancy and recommendation for definitive or palliative radiation to the head and neck, breast, lungs, upper GI structures, or pelvis.
4. Patient has ECOG performance status 0-2.
5. Patient will be receiving radiation therapy at University of Maryland Medical Center, Department of Radiation Oncology.
Exclusion Criteria:
1. Patient is pregnant or attempting pregnancy.
2. Patient has known genetic pre-disposition for sensitivity to radiation (e.g., Li Fraumeni).
3. Patient receives palliative radiation for 5 or fewer fractions.
4. 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.
Primary outcome measure(s)
Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning. — 1 year To evaluate the feasibility of HyperSight CBCT as a method for CBCT-based re-planning by measuring the fraction of patients whose HyperSight imaging meets criteria for potential CBCT-based treatment planning using HyperSight CBCT. The criteria include visibility of all key anatomical structures, image quality sufficient to contour anatomical structures, and clinically acceptable dose accuracy.
Trial sites (1)
Facility
City
Region
Status
University of Maryland Medical Center
Baltimore
Maryland
More Varian, a Siemens Healthineers Company trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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