Evaluation of Improved Onboard Patient Imaging

Varian

Status: Enrolling

Conditions: Breast Cancer; Pelvic Cancer; Upper Gastrointestinal Cancer; Lung Cancer; Head and Neck Cancer

Treatments: Device: HyperSight Imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT06187103

VAR-2023-05

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

HyperSight Imaging arm

Experimental group

Description:

Subjects are imaged with the new HyperSight CBCT imaging system.

Treatment:

Device: HyperSight Imaging