Evaluation of Improved Onboard Patient Imaging

Evaluation of Improved Onboard Patient Imaging With the HyperSight Platform on TrueBeam 4.1

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Head and Neck Cancer; Lung Cancer; Pelvic Cancer; Upper Gastrointestinal Cancer
• Intervention / Treatment: Device: HyperSight Imaging

• Study Type: Observational
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201-1544
      • University of Maryland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving radiation therapy in one of five anatomical regions: head/neck, breast, lungs, upper GI and pelvis.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HyperSight Imaging arm; Subjects are imaged with the new HyperSight CBCT imaging system.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning.	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning by anatomical site	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).	1 year
Image noise	To evaluate the imaging noise in HyperSight CBCT using clinical images and to compare this aspect of image quality to simulation CT images.	1 year
Image low-contrast resolution	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.	1 year
Image contrast-to-noise ratio	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.	1 year
Qualitative assessment of motion artifacts	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.	1 year
Qualitative assessment of metal artifacts	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..	1 year
Comparison of anatomical structure contours defined on HyperSight and conventional imaging.	To evaluate concordance of anatomical structures contoured on HyperSight with anatomical structures contoured on simulation CT as measured by the Dice Similarity Coefficient.	1 year
Comparison of anatomical structure contours defined on HyperSight and conventional imaging.	To evaluate concordance of anatomical structures contoured on HyperSight with anatomical structures contoured on simulation CT as measured by Hausdorff Distance.	1 year
Breath hold tolerance	To evaluate the number of breath holds required for patients with breast, thoracic, and upper GI malignancies during HyperSight CBCT imaging.	1-9 weeks
Patient experience of HyperSight imaging	To evaluate patient experience of HyperSight imaging. Patients will be asked to fill out a questionnaire. Questions will use a 5-point Likert scale.	1-9 weeks
Impact of noise suppression	HyperSight CBCT images will be reconstructed with different levels of noise suppression and compared qualitatively to CT simulation images of the same patient to identify regions adversely affected by too much or too little noise suppression. This evaluation will be performed for 1-2 subjects in each anatomical region.	1 year
Effectiveness of AI auto-contouring	The ability of AI auto-contouring to accurately contour structures on Hy[erSight CBCT will be evaluated (i) via qualitative user feedback on the accuracy of the auto-generated contours, and (ii) quantitatively using overlap metrics (Hausdorff Distance and Dice Similarity Coefficient) to compare auto-generated critical organs at risk to anatomical structures manually contoured on HyperSight CBCT.	1 year

Collaborators and Investigators

• Sponsor: Varian, a Siemens Healthineers Company

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Actual): December 5, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: CBCT
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Lung Neoplasms; Breast Neoplasms; Pelvic Neoplasms; Gastrointestinal Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: VAR-2023-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No