Evaluation of Improved Onboard Patient Imaging

Breast Cancer Clinical Trial

Official title:

Evaluation of Improved Onboard Patient Imaging With the HyperSight Platform on TrueBeam 4.0/4.1

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06187103
• Other study ID #: VAR-2023-05
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Varian, a Siemens Healthineers Company
• Contact: Sean Davidson
• Phone: 437-991-8294
• Email: sean.davidson[@]varian.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Gastrointestinal Neoplasms
• Head and Neck Cancer
• Lung Cancer
• Pelvic Cancer
• Pelvic Neoplasms
• Upper Gastrointestinal Cancer

Intervention

Device:
• HyperSight Imaging
Patients undergo 2 HyperSight CBCT acquisitions in addition to the standard imaging for treatment guidance. The HyperSight CBCT images will be acquired at the start of treatment, and approximately halfway through treatment. If the patient is sent for mid-treatment re-planning, a third HyperSight CBCT will be acquired on the same day as their re-simulation.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Varian, a Siemens Healthineers Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning.	To evaluate the feasibility of HyperSight CBCT as a method for CBCT-based re-planning by measuring the fraction of patients whose HyperSight imaging meets criteria for potential CBCT-based treatment planning using HyperSight CBCT. The criteria include visibility of all key anatomical structures, image quality sufficient to contour anatomical structures, and clinically acceptable dose accuracy.	1 year
Secondary	Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning by anatomical site	To break down the fraction of patients that meet criteria for potential CBCT-based treatment planning using HyperSight CBCT by anatomical site (head/neck, breast, lungs, upper GI tract, and pelvis).	1 year
Secondary	Image noise	To evaluate the imaging noise in HyperSight CBCT using clinical images and to compare this aspect of image quality to conventional CBCT and simulation CT images.	1 year
Secondary	Image low-contrast resolution	To evaluate contrast between adjacent anatomical structures in HyperSight CBCT using clinical images and to compare this aspect of image quality to conventional CBCT and simulation CT images.	1 year
Secondary	Image contrast-to-noise ratio	To measure the contrast-to-noise ratio of HyperSight CBCT using clinical images and to compare this aspect of image quality to conventional CBCT and simulation CT images.	1 year
Secondary	Qualitative assessment of motion artifacts	To evaluate the severity of motion artifacts observed in HyperSight CBCT using clinical images and to compare motion artifacts to conventional CBCT and simulation CT. Qualitative assessments will be performed by independent observers using a 5-point Likert scale.	1 year
Secondary	Qualitative assessment of metal artifacts	To evaluate the severity of metal artifacts observed in HyperSight CBCT in head & neck patients with dental fillings and pelvis patients with hip prostheses and compare metal artifacts between HyperSight CBCT, conventional CBCT, and simulation CT. Qualitative assessments will be performed by independent observers using a 5-point Likert scale.	1 year
Secondary	Comparison of anatomical structure contours defined on HyperSight and conventional imaging.	To evaluate concordance of target volumes and critical organs at risk contoured on HyperSight and conventional CBCT imaging compared to anatomical structures contoured on simulation CT. Concordance will be measured using the Dice Similarity Coefficient and Hausdorff Distance.	1 year
Secondary	Breath hold tolerance	To evaluate the tolerance of breath-hold duration for patients with breast, thoracic, and upper GI malignancies between conventional and HyperSight CBCT imaging.	1-9 weeks
Secondary	Patient experience of HyperSight imaging	To evaluate patient experience of HyperSight imaging compared to conventional CBCT imaging. Patients will be asked to fill out a questionnaire. Questions will use a 5-point Likert scale.	1-9 weeks