Feasibility Study of CBCT for IGRT in Cancer Patients

NCT ID: NCT06681233

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-19

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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HyperSight Imaging Arm

Group Type EXPERIMENTAL

Comparison of HyperSight CBCT imaging to conventional CBCT imaging.

Intervention Type 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.

Interventions

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Comparison of HyperSight CBCT imaging to conventional CBCT imaging.

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.

Intervention Type DEVICE

Eligibility Criteria

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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 therapy treatment plan being delivered

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 the study.
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 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Varian, a Siemens Healthineers Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Columbus, Ohio, United States

Site Status RECRUITING

Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sean Davidson

Role: CONTACT

437-991-8294

Facility Contacts

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Sujith Baliga, MD

Role: primary

614-293-8415

Nilendu Gupta, PhD

Role: backup

614-293-4204

Sujith Baliga, MD

Role: primary

614-293-8415

Nilendu Gupta, PhD

Role: backup

614-293-4204

Other Identifiers

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VAR-2023-04

Identifier Type: -

Identifier Source: org_study_id

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