RECRUITING

Feasibility Study of CBCT for IGRT in Cancer Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Feasibility Study of a Novel Cone-Beam CT Approach for Image Guided Radiotherapy in Cancer Patients

Quick Facts

Study Start:2025-02-19
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06681233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient age ≥ 18
  2. 2. Patient is receiving radiation therapy for head and neck, thorax, liver, breast, genitourinary, or gastrointestinal malignancies
  3. 3. A CBCT acquisition for localization is standard of care for the radiation therapy treatment plan being delivered
  1. 1. Patient has ECOG Performance Status ≥3.
  2. 2. Patient is wheelchair bound.
  3. 3. Patient has a life expectancy \<3 months.
  4. 4. Patient is unwilling or unable to provide informed consent to participate in the study.
  5. 5. Patient is pregnant or has plans for pregnancy during the period of treatment.
  6. 6. 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.

Contacts and Locations

Study Contact

Sean Davidson
CONTACT
437-991-8294
sean.davidson@varian.com

Study Locations (Sites)

The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Columbus, Ohio, 43210
United States
Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212
United States

Collaborators and Investigators

Sponsor: Varian, a Siemens Healthineers Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-19
Study Completion Date2026-09

Study Record Updates

Study Start Date2025-02-19
Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

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