Clinical trial NCT06681233: Feasibility Study of CBCT for IGRT in Cancer Patients
Official title: A Feasibility Study of a Novel Cone-Beam CT Approach for Image Guided Radiotherapy in Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancers
Breast Cancer
Thoracic Cancers
Liver Cancer
Genito Urinary Cancer
Gastrointestinal Cancers
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2024-11-08
Enrollment: 50
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 feasibility study designed to generate data evaluating the quality and applicability of the HyperSight on-couch high-performance CBCT imaging technology.
Primary purpose: OTHER

Brief summary: 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.


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.

Primary outcomes:
measure: Comparison of Image Contrast Resolution
timeFrame: End of radiation treatment at 9 weeks.
measure: Comparison of Image Uniformity
timeFrame: End of radiation treatment at 9 weeks.
measure: Qualitative Image Comparison
timeFrame: End of radiation treatment at 9 weeks.
Secondary outcomes:
measure: Reduction of Metal Artifacts
timeFrame: End of radiation treatment at 9 weeks.
measure: Imaging Time for Large Treatment Volumes
timeFrame: End of radiation treatment at 9 weeks.
measure: Imaging Time for Breath Hold Imaging
timeFrame: End of radiation treatment at 9 weeks.
measure: Patient Tolerance of Breath Hold Imaging
timeFrame: End of radiation treatment at 9 weeks.
measure: Feasibility of HyperSight CBCT for Treatment Planning
timeFrame: End of radiation treatment at 9 weeks.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
state: Ohio
city: Columbus
country: United States
facility: Stefanie Spielman Comprehensive Breast Center
state: Ohio
Study officials:
References: