Feasibility Study of CBCT for IGRT in Cancer Patients

NCT06681233 | Recruiting FDA Device

• 1 other identifier: VAR-2023-04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

Cone beam computed tomography (CBCT) is an imaging technology that is incorporated into many modern radiation therapy systems. The quality of conventional CBCT is good enough to align patients for their daily radiation therapy but CBCT images have poor contrast and are susceptible to imaging artefacts that limit their usability for other tasks in the radiation therapy workflow. Varian Medical Systems, the sponsor of this study, has developed new CBCT imaging technology called HyperSight that so far has demonstrated increased image quality compared with conventional CBCT images. This new HyperSight CBCT imager has previously been built into Varian Halcyon and Ethos treatment machines, where the imager is enclosed in a ring that rotates around the patient. Now, HyperSight has been built into a Varian treatment machine, called TrueBeam, where the imager is mounted on a C-shaped arm that rotates around you to acquire an image. This study is being done to evaluate the image quality of HyperSight CBCT compared to conventional CBCT images, and to determine whether HyperSight CBCT can improve the process of delivering radiation treatments. The goal of this study is to collect images from this new HyperSight-TrueBeam CBCT imager from a variety of patients and locations in the body. The images will be analyzed to determine whether their quality is high enough to use for tasks other than positioning patients for treatment. For example, the study will determine whether the HyperSight images could be used to calculate a radiation plan.

Conditions

Head and Neck Cancers; Breast Cancer; Liver Cancer; Thoracic Cancers; Genito Urinary Cancer; Gastrointestinal Cancers

Outcome Measures

Primary Outcomes (3)

• Comparison of Image Contrast Resolution

  The difference in contrast resolution will be evaluated between a standard CBCT image, a CBCT image acquired using HyperSight technology, and a standard fan-beam CT acquired as part of the treatment simulation and planning process

  End of radiation treatment at 9 weeks.

• Comparison of Image Uniformity

  The difference in image uniformity will be evaluated between a standard CBCT image, a CBCT image acquired using HyperSight technology, and a standard fan-beam CT acquired as part of the treatment simulation and planning process.

  End of radiation treatment at 9 weeks.

• Qualitative Image Comparison

  Qualitative comparison of HyperSight CBCT to conventional CBCT to determine preferred imaging for patient localization for daily treatment. Clinician observers will rank their preference using a 5-point Likert scale, where 1 represents strong preference of one imaging modality and 5 represents strong preference for the other modality.

  End of radiation treatment at 9 weeks.

Secondary Outcomes (5)

• Reduction of Metal Artifacts

  End of radiation treatment at 9 weeks.

• Imaging Time for Large Treatment Volumes

  End of radiation treatment at 9 weeks.

• Imaging Time for Breath Hold Imaging

  End of radiation treatment at 9 weeks.

• Patient Tolerance of Breath Hold Imaging

  End of radiation treatment at 9 weeks.

• Feasibility of HyperSight CBCT for Treatment Planning

  End of radiation treatment at 9 weeks.

Study Arms (1)

HyperSight Imaging Arm

EXPERIMENTAL

Device: Comparison of HyperSight CBCT imaging to conventional CBCT imaging.

Interventions

Comparison of HyperSight CBCT imaging to conventional CBCT imaging. DEVICE

Participants will receive their daily radiation treatment on a radiation therapy system equipped with HyperSight CBCT imaging. For at least 1 and up to 3 treatment fractions, participants will receive their daily radiation treatment on a system equipped with conventional CBCT imaging.

HyperSight Imaging Arm

Eligibility Criteria

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

You may qualify if:

• Patient age ≥ 18
• Patient is receiving radiation therapy for head and neck, thorax, liver, breast, genitourinary, or gastrointestinal malignancies
• A CBCT acquisition for localization is standard of care for the radiation therapy treatment plan being delivered

You may not qualify if:

• Patient has ECOG Performance Status ≥3.
• Patient is wheelchair bound.
• Patient has a life expectancy \<3 months.
• Patient is unwilling or unable to provide informed consent to participate in the study.
• Patient is pregnant or has plans for pregnancy during the period of treatment.
• 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 (4)

James Outpatient Center

Columbus, Ohio, 43210, United States

RECRUITING

Ohio State University, Brain and Spine Hospital

Columbus, Ohio, 43210, United States

RECRUITING

The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

Columbus, Ohio, 43210, United States

RECRUITING

Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, 43212, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Breast Neoplasms; Liver Neoplasms; Urogenital Neoplasms; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Gastrointestinal Diseases

Central Study Contacts

Sean Davidson

CONTACT

437-991-8294; sean.davidson@varian.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-arm, single-site feasibility study designed to generate data evaluating the quality and applicability of the HyperSight on-couch high-performance CBCT imaging technology.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: February 19, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)