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NCT Number: NCT06576908

Evaluation of On-Couch CBCT Image Quality

This is a prospective, single-arm, single-site study designed to generate data describing the image quality and applicability/useability of a high-performance, on-couch CBCT imaging technology (HyperSight) in patients receiving radiation treatment for cancer on a C-arm linear accelerator (TrueBeam).

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Key information

Conditions

Head and Neck Cancer Abdominal Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Pelvic Cancer Pelvic Neoplasms Thoracic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre (University Health Network)

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient age is ≥ 18 years old.
  • Patient has a diagnosis of primary or metastatic cancer, including but not limited to tumors arising from or involving the head/neck, lungs, liver, pancreas, prostate, urinary bladder, rectum, cervix or uterus.
  • A previous (standard-of-care) decision was made to treat the patient with radiation therapy using a Varian TrueBeam treatment system.
  • A previous (standard-of-care) decision was made to treat the patient with a radiation dose of at least 20 Gy in at least 5 fractions, one fraction per day on consecutive days, Monday to Friday.
  • Patient is willing and able to provide informed consent to participate in the study.

Exclusion criteria

  • 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").

Treatment and study plan

HyperSight imaging

Device

Subjects receive both HyperSight imaging and conventional imaging, on their first day of radiation treatment, on their second day of treatment, and on their last day of treatment.

Primary outcomes

  1. Comparison of overall free-breathing image quality: HyperSight CBCT vs Conventional CBCT

    Time frame: Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).

    Semi-quantitative scoring (5-point Likert scale) of on-treatment, free-breathing HyperSight-TrueBeam CBCT images compared to on-treatment, free-breathing conventional TrueBeam CBCT images by three independent observers. The Likert scale values will represent a range of opinion from strong preference for HyperSight-TrueBeam CBCT images to strong preference for conventional TrueBeam CBCT images.

Secondary outcomes

  1. Comparison of overall image quality: HyperSight CBCT vs Computed Tomography (CT) simulation images

    Time frame: Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).

    Semi-quantitative scoring (5-point Likert scale) of on-treatment HyperSight-TrueBeam CBCT images compared to pre-treatment, diagnostic-quality, planning CT images by three independent observers. The Likert scale values will represent a range of opinion from strong preference for HyperSight-TrueBeam CBCT images to strong preference for planning CT images.

  2. Comparison of motion artifacts: HyperSight CBCT vs. Conventional CBCT

    Time frame: Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).

    Semi-quantitative scoring (5-point Likert scale) of motion artifacts in HyperSight-TrueBeam CBCT images compared to on-treatment conventional TrueBeam CBCT images by three independent observers. The Likert scale values will represent a range of opinion from strong preference for HyperSight-TrueBeam CBCT images to strong preference for conventional TrueBeam CBCT images.

  3. Comparison of metal artifacts: HyperSight CBCT vs. Conventional CBCT

    Time frame: Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).

    Semi-quantitative scoring (5-point Likert scale) of metal artifacts in HyperSight-TrueBeam CBCT images compared to on-treatment conventional TrueBeam CBCT images by three independent observers. The Likert scale values will represent a range of opinion from strong preference for HyperSight-TrueBeam CBCT images to strong preference for conventional TrueBeam CBCT images.

  4. Comparison of overall breath hold image quality: HyperSight CBCT vs Conventional CBCT

    Time frame: Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).

    Semi-quantitative scoring (5-point Likert scale) of on-treatment, breath-hold HyperSight-TrueBeam CBCT images compared to on-treatment, breath-hold conventional TrueBeam CBCT images by three independent observers. The Likert scale values will represent a range of opinion from strong preference for HyperSight-TrueBeam CBCT images to strong preference for conventional TrueBeam CBCT images.

  5. Comparison of Hounsfield Unit accuracy: HyperSight CBCT vs Conventional CBCT and CT Simulation images

    Time frame: Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).

    The HU accuracy of clinical HyperSight-TrueBeam CBCTs will be evaluated by comparing mean HUs and SDs for regions of interest in different tissue types (muscle, fat, lungs, and bones) on the planning CTs, HyperSight-TrueBeam CBCTs, and conventional TrueBeam CBCT.

  6. Patient's perspectives of on-treatment HyperSight-TrueBeam CBCT

    Time frame: Day 1 of radiation treatment and the last day of radiation treatment (up to 6 weeks after the start of treatment).

    Semi-structured interview integrating the validated six-item State Anxiety scale derived from the State-Tait Anxiety Inventory.

  7. Patient tolerability of on-treatment, breath-hold HyperSight-TrueBeam CBCT imaging.

    Time frame: Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).

    Proportion of patients able to complete HyperSight-TrueBeam CBCT breath-hold imaging in a single breath-hold compared to conventional TrueBeam CBCT breath-hold imaging.

  8. Patient tolerability of on-treatment, breath-hold HyperSight-TrueBeam CBCT imaging.

    Time frame: Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).

    Number of breath-holds required to complete HyperSight-TrueBeam CBCT breath-hold imaging compared to conventional TrueBeam CBCT breath-hold imaging.

  9. Breath hold imaging time

    Time frame: Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).

    Total HyperSight-TrueBeam CBCT breath-hold image acquisition time compared to conventional TrueBeam CBCT breath-hold imaging.

Sponsors and collaborators

Lead sponsor

Varian, a Siemens Healthineers Company

Industry

Registry information

Official study title

Evaluation of Image Quality From an On-Couch, Cone Beam Computed Tomography (CBCT) Radiation Treatment System for Image Guidance and Treatment Adaptation

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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