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Feasibility Study of CBCT for IGRT in Cancer Patients

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Cone beam computed tomography (CBCT) is an imaging technology that is incorporated into many modern radiation therapy systems."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares images from the new HyperSight scanner on a TrueBeam radiation machine with standard CBCT scans, which make 3D images of the body. It will test whether the new images could help plan and deliver radiation treatment. It is for adults getting radiation treatment for certain cancers who already need CBCT scans to check their position.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You are getting radiation treatment for cancer in the head and neck, chest, liver, breast, urinary or reproductive organs, or digestive system.
  • Your regular treatment plan includes CBCT scans to check your position for radiation treatment.

Who can't join

  • You have an ECOG score of 3 or higher, meaning you need much help with daily care and spend more than half your waking hours in bed or a chair.
  • You are limited to using a wheelchair.
  • You are expected to live less than 3 months.
  • You cannot or do not want to give informed consent, which means understanding the study and agreeing to join.
  • You are pregnant or plan to become pregnant during treatment.
  • You are in a vulnerable group, including prisoners. This means you may not fully understand the study or may be easily pressured to join because of your situation, hopes for benefits, or fear of punishment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (4)

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