Evaluation of Improved Onboard Patient Imaging

NCT06187103 | Active Not Recruiting FDA Device

• 1 other identifier: VAR-2023-05
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer; Breast Cancer; Upper Gastrointestinal Cancer; Lung Cancer; Pelvic Cancer

Keywords

CBCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning by anatomical site

  1 year

• Image noise

  1 year

• Image low-contrast resolution

  1 year

• Image contrast-to-noise ratio

  1 year

• Qualitative assessment of motion artifacts

  1 year

Study Arms (1)

HyperSight Imaging arm

Subjects are imaged with the new HyperSight CBCT imaging system.

Device: HyperSight Imaging

Interventions

HyperSight Imaging DEVICE

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.

HyperSight Imaging arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patient is pregnant or attempting pregnancy.
• 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.

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201-1544, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Breast Neoplasms; Gastrointestinal Neoplasms; Lung Neoplasms; Pelvic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 2, 2024
• Study Start: July 10, 2024
• Primary Completion: December 5, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)