Evaluation of Improved Onboard Patient Imaging
- Conditions
- Pelvic CancerBreast CancerLung CancerHead and Neck CancerUpper Gastrointestinal Cancer
- Interventions
- Device: HyperSight Imaging
- Registration Number
- NCT06187103
- Lead Sponsor
- Varian, a Siemens Healthineers Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Patient is willing and able to provide written consent.
- Patient is at least 18 years of age at the time of consent.
- Patient has biopsy confirmed malignancy and recommendation for definitive or palliative radiation to the head and neck, breast, lungs, upper GI structures, or pelvis.
- Patient has ECOG performance status 0-2.
- Patient will be receiving radiation therapy at University of Maryland Medical Center, Department of Radiation Oncology.
- Patient is pregnant or attempting pregnancy.
- Patient has implanted cardiac devices or nerve stimulation devices.
- Patient has known genetic pre-disposition for sensitivity to radiation (e.g., Li Fraumeni).
- Patient receives palliative radiation for 5 or fewer fractions.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HyperSight Imaging arm HyperSight Imaging Subjects are imaged with the new HyperSight CBCT imaging system.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Comparison of anatomical structure contours defined on HyperSight and conventional imaging. 1 year To evaluate concordance of anatomical structures contoured on HyperSight with anatomical structures contoured on simulation CT as measured by Hausdorff Distance.
Breath hold tolerance 1-9 weeks To evaluate the number of breath holds required for patients with breast, thoracic, and upper GI malignancies during HyperSight CBCT imaging.
Patient experience of HyperSight imaging 1-9 weeks To evaluate patient experience of HyperSight imaging. Patients will be asked to fill out a questionnaire. Questions will use a 5-point Likert scale.
Qualitative assessment of motion artifacts 1 year To evaluate the severity of motion artifacts observed in HyperSight CBCT using clinical images and to compare motion artifacts to simulation CT. Qualitative assessments will be performed by independent observers using a 5-point Likert scale.
Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning by anatomical site 1 year To break down the fraction of patients that meet criteria for potential CBCT-based treatment planning using HyperSight CBCT by anatomical site (head/neck, breast, lungs, upper GI tract, and pelvis).
Image noise 1 year To evaluate the imaging noise in HyperSight CBCT using clinical images and to compare this aspect of image quality to simulation CT images.
Image low-contrast resolution 1 year To evaluate contrast between adjacent anatomical structures in HyperSight CBCT using clinical images and to compare this aspect of image quality to simulation CT images.
Image contrast-to-noise ratio 1 year To measure the contrast-to-noise ratio of HyperSight CBCT using clinical images and to compare this aspect of image quality to simulation CT images.
Qualitative assessment of metal artifacts 1 year To evaluate the severity of metal artifacts observed in HyperSight CBCT in head \& neck patients with dental fillings and pelvis patients with hip prostheses and compare metal artifacts between HyperSight CBCT and simulation CT. Qualitative assessments will be performed by independent observers using a 5-point Likert scale, with a score of 1 representing very severe metal artifacts and a score of 5 representing little or no artifact..
Trial Locations
- Locations (1)
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States