Feasibility Study of CBCT for IGRT in Cancer Patients

Last updated: February 28, 2025
Sponsor: Varian, a Siemens Healthineers Company
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

Comparison of HyperSight CBCT imaging to conventional CBCT imaging.

Clinical Study ID

NCT06681233
VAR-2023-04
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient age ≥ 18

  2. Patient is receiving radiation therapy for head and neck, thorax, liver, breast,genitourinary, or gastrointestinal malignancies

  3. A CBCT acquisition for localization is standard of care for the radiation therapytreatment plan being delivered

Exclusion

Exclusion Criteria:

  1. Patient has ECOG Performance Status ≥3.

  2. Patient is wheelchair bound.

  3. Patient has a life expectancy <3 months.

  4. Patient is unwilling or unable to provide informed consent to participate in thestudy.

  5. Patient is pregnant or has plans for pregnancy during the period of treatment.

  6. Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who areunable to fully understand all aspects of the investigation that are relevant to thedecision to participate, or who could be manipulated or unduly influenced as aresult of a compromised position, expectation of benefits or fear of retaliatoryresponse"). This includes prisoners.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Comparison of HyperSight CBCT imaging to conventional CBCT imaging.
Phase:
Study Start date:
February 19, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Stefanie Spielman Comprehensive Breast Center

    Columbus, Ohio 43212
    United States

    Active - Recruiting

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

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

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