Clinical trial NCT06187103: Evaluation of Improved Onboard Patient Imaging
Official title: Evaluation of Improved Onboard Patient Imaging With the HyperSight Platform on TrueBeam 4.1
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Breast Cancer
Upper Gastrointestinal Cancer
Lung Cancer
Pelvic Cancer
Keywords: CBCT
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2024-01-02
Enrollment: 40
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 describing the quality and applicability of on-couch high-performance CBCT imaging technology.
Primary purpose: OTHER

Brief summary: The primary objective of radiation therapy is to deliver a therapeutic dose of radiation precisely to the target while minimizing exposure to healthy surrounding tissues. Image-guided radiation therapy (IGRT) involves acquiring cone beam computed tomography (CBCT) scans just before or during treatment sessions. By comparing the CBCT images with the reference images from the treatment planning process, clinicians can make necessary adjustments to ensure precise targeting and account for any changes that may have occurred since the initial planning. Conventional CBCT technology is, however, limited by several factors including long acquisition times that result in motion artifacts in the image, smaller fields of view that limit the volume of anatomy that can be imaged, poor image quality that limits soft tissue visibility, and artifacts created by dense metal implants. This study will evaluate a novel CBCT imaging solution ("HyperSight") that has the potential to address the challenges of conventional CBCT.


Eligibility criteria: Inclusion Criteria:

1. Patient is willing and able to provide written consent.
2. Patient is at least 18 years of age at the time of consent.
3. Patient has biopsy confirmed malignancy and recommendation for definitive or palliative radiation to the head and neck, breast, lungs, upper GI structures, or pelvis.
4. Patient has ECOG performance status 0-2.
5. Patient will be receiving radiation therapy at University of Maryland Medical Center, Department of Radiation Oncology.

Exclusion Criteria:

1. Patient is pregnant or attempting pregnancy.
2. Patient has implanted cardiac devices or nerve stimulation devices.
3. Patient has known genetic pre-disposition for sensitivity to radiation (e.g., Li Fraumeni).
4. Patient receives palliative radiation for 5 or fewer fractions.
5. 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: Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning.
timeFrame: 1 year
Secondary outcomes:
measure: Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning by anatomical site
timeFrame: 1 year
measure: Image noise
timeFrame: 1 year
measure: Image low-contrast resolution
timeFrame: 1 year
measure: Image contrast-to-noise ratio
timeFrame: 1 year
measure: Qualitative assessment of motion artifacts
timeFrame: 1 year
measure: Qualitative assessment of metal artifacts
timeFrame: 1 year
measure: Comparison of anatomical structure contours defined on HyperSight and conventional imaging.
timeFrame: 1 year
measure: Comparison of anatomical structure contours defined on HyperSight and conventional imaging.
timeFrame: 1 year
measure: Breath hold tolerance
timeFrame: 1-9 weeks
measure: Patient experience of HyperSight imaging
timeFrame: 1-9 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
References: