Clinical trial NCT06576908: Evaluation of On-Couch CBCT Image Quality
Official title: Evaluation of Image Quality From an On-Couch, Cone Beam Computed Tomography (CBCT) Radiation Treatment System for Image Guidance and Treatment Adaptation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Thoracic Cancer
Abdominal Cancer
Pelvic Cancer
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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).


Eligibility criteria: 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").

Primary outcomes:
measure: Comparison of overall free-breathing image quality: HyperSight CBCT vs Conventional CBCT
timeFrame: 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:
measure: Comparison of overall image quality: HyperSight CBCT vs Computed Tomography (CT) simulation images
timeFrame: 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).
measure: Comparison of motion artifacts: HyperSight CBCT vs. Conventional CBCT
timeFrame: 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).
measure: Comparison of metal artifacts: HyperSight CBCT vs. Conventional CBCT
timeFrame: 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).
measure: Comparison of overall breath hold image quality: HyperSight CBCT vs Conventional CBCT
timeFrame: 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).
measure: Comparison of Hounsfield Unit accuracy: HyperSight CBCT vs Conventional CBCT and CT Simulation images
timeFrame: 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).
measure: Patient's perspectives of on-treatment HyperSight-TrueBeam CBCT
timeFrame: Day 1 of radiation treatment and the last day of radiation treatment (up to 6 weeks after the start of treatment).
measure: Patient tolerability of on-treatment, breath-hold HyperSight-TrueBeam CBCT imaging.
timeFrame: 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).
measure: Patient tolerability of on-treatment, breath-hold HyperSight-TrueBeam CBCT imaging.
timeFrame: 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).
measure: Breath hold imaging time
timeFrame: 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).
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre (University Health Network)
state: Ontario
Study officials:
References: