Evaluation of On-Couch CBCT Image Quality

NCT06576908 | Completed FDA Device

• 1 other identifier: VAR-2023-07
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Head and Neck Cancer; Thoracic Cancer; Abdominal Cancer; Pelvic Cancer

Outcome Measures

Primary Outcomes (1)

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

  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.

  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).

Secondary Outcomes (9)

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

  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).

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

  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).

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

  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).

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

  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).

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

  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).

Study Arms (1)

HyperSight Imaging arm

EXPERIMENTAL

Subjects have both HyperSight and conventional CBCT imaging.

Device: HyperSight Imaging

Interventions

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.

HyperSight Imaging arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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").

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (1)

Princess Margaret Cancer Centre (University Health Network)

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Pelvic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 in patients receiving radiation treatment for cancer.

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 29, 2024
• Study Start: October 17, 2024
• Primary Completion: April 23, 2026
• Study Completion: April 23, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)