Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Lung Neoplasms

Breast Neoplasms

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Two additional study imaging sets are acquired.

Two research CBCT images will be acquired per subject.

CBCT Imaging

This is a feasibility study investigating the image quality of a new, high-performance cone beam CT (CBCT) used for on-couch imaging during radiotherapy treatments.

This study focuses on potential benefits of a high performance cone beam CT (CBCT) image guidance system for improved precision in the delivery of radiotherapy. CBCT is currently used during radiation therapy to align the patient to their original treatment plan to increase the precision of radiation delivery. Current CBCT imaging technology requires approximately a minute to acquire an image. In order to acquire images with sufficient quality to allow accurate targeting, the patient may need to perform multiple breath hold maneuvers to "freeze" the motion of tumors that move with the breathing cycle (e.g. lung, liver, and breast tumors). The new high-performance CBCT can acquire an image in approximately 6 seconds, potentially enabling acquisition of images with a single breath hold. Improved motion compensation algorithms used in image reconstruction may allow acquisition of good quality images even while a patient is not holding their breath.

The methodology for the subject's treatment setup, CT simulation, treatment planning, image guidance and treatment delivery will be determined by the subject's treatment team and is not specified by this study. Enrollment in the study may occur after treatment delivery has started but must be prior to the fifth fraction.

Following completion of informed consent to participate in this study, high-performance CBCT imaging will be scheduled immediately before or after one of the subject's first five scheduled radiation treatment fractions. Two research CBCT images will be acquired, one with breath hold, the other with free breathing.

With minimal disruption for participating patients, this study will enable a comparison of (i) the subject's treatment planning fan-beam CT and (ii) the conventional CBCT acquired on an existing treatment unit with (iii) the high-performance CBCT. Image quality of the high performance CBCT image data will thereby be compared to both a best-case standard (fan-beam) and the status-quo for on-couch imaging to isolate and identify improvements.

This is a single-site study designed to generate data describing the quality and applicability of on-couch high-performance CBCT imaging for anatomy visualization and radiation treatment dosimetry planning.

Evaluation of Novel Cone-Beam CT for Guidance and Adaptation of Precision Radiotherapy

The quality of fan-beam CT, standard CBCT and high-performance CBCT will be evaluated by calculating contrast, noise, resolution, Hounsfield Unit accuracy and artifact reduction.

Furthermore, the three image sets will be evaluated qualitatively by multiple observers with training in radiation oncology and image-guided radiation therapy, who will rank the images acquired for each subject by perceived quality/usefulness for structure contouring and RT guidance.

Dose-volume histograms for key target structures and organs at risk will be calculated from both the high-performance and standard CBCT images and compared to those from the existing dosimetric plan for each subject to determine the accuracy of the dosimetric calculations based on the CBCTs.

The patient experience with CBCT image acquisition will be determined through the use of a questionnaire comparing elements of the standard CBCT image acquisition process to that of the high-performance CBCT process.

Varian, a Siemens Healthineers Company

Head and Neck Neoplasms

Subjects imaged with the new HyperSight CBCT imaging system.

Subjects are scheduled for two imaging sessions on the Ethos system with the HyperSight CBCT. One session is on the same day as the CT simulation scan for treatment planning. The second session is on the same day as the delivery of ther 21st treatment fraction. If the subject is sent for a mid-treatment FBCT for re-planning, a third HyperSight CBCT imaging session will be scheduled on the same day as the mid-treatment FBCT.

Sean Davidson, MASc

Claire McCann, PhD

Amanda Cherpak, PhD

Derek Wilke, MD

Lee MacDonald, PhD

This is a feasibility study investigating the use of a high-performance HyperSight cone beam CT (CBCT) and adaptive planning software for both online and offline radiotherapy treatment planning for head and neck cancer.

This study focuses on imaging and radiotherapy treatment plan modification for head \& neck cancer patients using a high-performance cone beam CT (CBCT) image guidance system (HyperSight) and AI-driven adaptive planning software. The HyperSight imaging system is a forthcoming component of a radiation therapy (RT) treatment platform, called Ethos (Varian Medical Systems).

RT is used in the treatment of approximately 75% of all head and neck (H\&N) cancers with either curative or palliative intent. External beam radiation therapy is typically delivered over 5-7 weeks in 25-35 daily treatments (or "fractions"). Image guided radiation therapy (IGRT) is now a standard of care for external beam radiotherapy. During an IGRT treatment session, a CBCT imaging system built into the treatment unit is used to acquire 3D images of the patient's anatomy immediately prior to, and, if required, at several time points during, the daily delivery of radiation. The CBCT image data are used by the treatment team to carefully align the patient to a treatment planning fan-beam CT (FBCT) images that was acquired 1-2 weeks prior to the start of treatment, and which was used to generate the dosimetry plan that determines the daily radiation delivery. Verification of the patient position and alignment with the treatment planning images increases the precision of radiation delivery.

Daily imaging is particularly important for accurate setup of patients treated for head and neck (H\&N) cancer, as these patients often experience weight loss and target volume changes throughout the course of treatment. These volume changes can alter the expected dose distribution, as organs at risk (OAR) migrate to high dose regions or target volumes develop inhomogeneities. When volume changes are perceived by the treatment team to have a significant impact on radiation delivery, patients may be sent for a second planning FBCT and have a new treatment plan created for the remainder of their treatment. This process is referred to as offline replanning or offline adaptation. The radiation oncologist must decide whether to pause treatment or continue with the original treatment plan until a new plan is created. In either case, it can take several days between the point when an issue is identified and when a new plan is ready to be delivered. Offline replanning is not a regularly scheduled part of the clinical workflow and creates disruption of routine imaging, contouring and planning tasks for other patients. These tasks must be moved aside to free the necessary resources to create a new plan for the patient who is already receiving treatment and to permit the treatment team to start delivering the new plan as soon as possible.

The CBCT images acquired with the high-performance HyperSight CBCT imaging system have demonstrated Hounsfield Unit accuracy sufficient for accurate dosimetry calculations in phantoms. These images can therefore potentially be used to plan, or re-plan a radiation treatment delivery. The ability to use imaging that is acquired as part of the daily treatment delivery for re-planning could reduce the need to send patients for additional imaging and could also reduce the time and resources required to re-plan treatment delivery mid-course. This is of great importance for a cohort of patients already known to be vulnerable to the need for replanning.

In addition to the challenges involved in mid-treatment re-planning, another issue commonly encountered in H\&N patients is the presence of imaging artifacts from high-density metal objects in their oral cavity such as dental fillings and implants. These artifacts can cause difficulties in visualization of target volumes and OARs on planning CT as well as perturbation of dose calculation, particularly for cancers in the oral cavity. Metal artifacts can also cause a significant reduction in CBCT image quality, limiting the usefulness of IGRT for patient positioning.

The HyperSight CBCT imaging system incorporates several hardware and software changes that have the potential to provide higher quality CBCT images including improved visualization of volume changes and improved metal artifact reduction.

With minimal disruption for participating patients, this study will enable a comparison of (i) the patient's treatment planning FBCT and (ii) the patient's conventional CBCT on an existing treatment unit (Truebeam CBCT) with (iii) patient CBCT images on the HyperSight system. Image quality of the high performance CBCT will thereby be compared to both a best-case standard (FBCT) and the conventional CBCT for IGRT (Truebeam CBCT) to identify potential improvements in the HyperSight CBCT images. Image quality will be quantified in terms of contrast-to-noise ratio (CNR), resolution, Hounsfield Unit (HU) accuracy and artifact reduction with a focus on anatomy germane to the image guidance task. A qualitative assessment of the different image datasets will also be performed through feedback from multiple observers (radiation oncologists and radiation therapists). Radiation doses to key targets and organs at risk will be calculated from the high performance CBCTs and compared to the doses calculated in the subject's treatment plan to determine the suitability of the CBCT images for RT dosimetric planning. Various re-planning scenarios will also be examined to determine potential increases in efficiency from using the HyperSight CBCT imaging system for re-planning.

Image sets (i) and (ii) above are already acquired as part of standard-of-care for radiation treatment. Two additional CBCTs, taken on the day of the patient's treatment planning FBCT and again on the day the patients receive their 21st treatment fraction (approximately two-thirds through treatment) will be acquired from each subject on the HyperSight CBCT imaging system for this study. Not every patient will require mid-treatment re-planning but based on prior institutional data, if re-planning is required, the indications for re-planning should be evident in most of that population by the time 2/3 of their treatment has been delivered. If the treatment team determines that a patient requires a second planning FBCT during treatment, the patient will be scheduled for a third HyperSight CBCT on the same day that they receive their second planning FBCT.

Radiation treatment planning and delivery will not be altered due to patients' participation in this study. Patients will receive radiotherapy according to current departmental procedures and on the department's existing linear accelerator platforms. The decision to obtain a second planning CT and to generate a new mid-treatment plan will not be affected by a subject's participation in the study.

The HyperSight CBCTs that are acquired in this study will allow the examination of several re-planning strategies. The process of mid-treatment re-planning can be simulated for all subjects using the HyperSight CBCT acquired at fraction 21. Timing and workflow efficiencies can be evaluated in these simulated re-planning processes and compared to institutional norms (e.g., average time from identification of the need for re-planning to the start of delivery of a new treatment plan). In the subset of study subjects who require re-planning as part of their treatment, the HyperSight CBCTs acquired on the day of the second FBCT will also be used to generate a treatment plan and the dosimetry of the HyperSight CBCT-based re-plan will be compared to the dosimetry of the mid-treatment re-plans generated for these subjects using the current offline re-planning methods.

In addition to the simulation of current offline re-planning methods using the HyperSight CBCT images, this study will evaluate the online adaptive workflow that is available through the Ethos Radiotherapy System. Online adaptive workflow leverages AI-based anatomical structure contouring and plan optimization tools to adjust the daily radiation treatment delivery. Instead of delivering the same treatment in every fraction, the treatment plan defined prior to the start of treatment is optimized based on the anatomy captured in the CBCT acquired at the start of the daily fraction. Independent of the patient's clinical treatment plan, the AI-driven adaptive planning component of Ethos will be used to simulate online adaptation of the treatment plan. This study will evaluate the potential dosimetric benefits of daily online adaptive planning in Head and Neck cancer and the potential for online adaptation to reduce the need for offline re-planning. The time and resources required to implement an online adaptive workflow will be compared to standard IGRT delivery.

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 during external beam radiation therapy for head and neck cancer patients.

On-treatment Adaptation of Head and Neck Cancer Dosimetry Plans Using Novel Cone-beam CT and AI-driven Software

The treatment plan calculated on a subject's fan beam simulation CT will be re-calculated on both the HyperSight CBCT acquired on the day of the subject's simulation CT and on the TrueBeam CBCT used for subject positioning during fraction 1 of treatment delivery. Dose-volume histograms for targets and key organs at risk will be compared between the three dose calculations from each subject.

The workflow and opportunity for improved efficiency when using HyperSight CBCT images for offline treatment adaptation, will be compared to the standard process of obtaining a separate FBCT for re-planning. The average time required to generate a revised treatment plan will be measured and compared to institutional norms.

The HyperSight CBCT acquired on the same day as the subject's 21st treatment fraction delivery will be used to simulate an online adaptive radiotherapy session, which will produce a treatment plan that is adapted to the anatomy as it appears on that day. The target dose coverage and doses delivered to key organs at risk in the adaptive plan will be compared to the doses that are delivered to those structures by the subject's initial treatment plan.

Paired HyperSight CBCT and Truebeam CBCT images will be presented to radiation oncologists and radiation therapists, who will rank the images using a Likert scale for the ability to identify significant anatomical structure volume changes that prompt the need for on-treatment replanning.

The quality of HyperSight CBCT images will be evaluated my measuring contrast-to-noise ratio, resolution, and Hounsfield Unit accuracy. The quality metrics of the HyperSight CBCT images will be compared to those of the fan beam planning CT images and to those of the standard TrueBeam CBCT images. Metal artifact reduction will be compared between images of subjects with dental or other metal implants in the imaging field.

Subjects will be presented with a questionnaire in which they will be asked to compare their experience of imaging on a fan beam planning CT system to their experience of imaging with the HyperSight CBCT imaging system.

Breast Diseases

Skin Diseases

Anti-Infective Agents

All Drugs and Chemicals

Metronidazole

whole breast irradiation, CBCT imaging at first and last fraction of radiotherapy treatment

simultaneous integrated boost, CBCT imaging at first and last fraction of radiotherapy treatment

patients with seroma at start radiation treatment (whole breast irradiation or simultaneous integrated boost), CBCT imaging at first and last fraction of radiotherapy treatment

CBCT imaging at first and last fraction of radiotherapy treatment

CBCT imaging

Karolien Verhoeven, PHD

In a retrospective study the investigators defined quantitative action levels based on dose and volume measures for adaptive radiation therapy in breast cancer patients (Zegers et al. Acta Oncol 2017). The aim of this study is to validate these parameters in a prospective study.

During radiotherapy, changes in patient anatomy or positioning can result into differences in dose deposition, which is the main factor influencing tumor control or side-effects. Dose-guided radiation therapy is the systematic evaluation of the dose delivery during treatment for an individual patient with the aim to adapt the treatment if needed. Recalculation of the dose during treatment can be performed using the imaging information during treatment. In a retrospective study the investigators defined quantitative action levels based on dose and volume measures for adaptive radiation therapy in breast cancer patients (Zegers et al. Acta Oncol 2017). The aim of this study is to validate these parameters in a prospective study.

Prospective Validation of 3D Dose Metrics as Selection Criteria for Adaptive Radiotherapy in Breast Cancer Patients

Evaluation of DVH parameters on the CBCT of the 1st and last fraction of radiotherapy treatment. Evaluate if the changes during treatment are within the thresholds set by the previous retrospective study; are parameters within predefined criteria yes/no

Evaluation of automatic re-delineation of the target volume against manual re-delineation by a radiotherapy oncologist on the CBCT of the 1st and last fraction of radiotherapy treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Novel Cone-Beam CT for Guidance and Adaptation of Precision Radiotherapy	NCT05176860	Lung Cancer Liver Cancer Breast Cancer Other Cancer	CBCT Imaging	19 Years -	Varian, a Siemens Healthineers Company
On-treatment Adaptation of Head and Neck Cancer Dosimetry Plans Using Novel Cone-beam CT and AI-driven Software	NCT05666193	Head and Neck C...	CBCT Imaging	19 Years -	Varian, a Siemens Healthineers Company
Prospective Validation of 3D Dose Metrics as Selection Criteria for Adaptive Radiotherapy in Breast Cancer Patients	NCT03385031	Breast Cancer	CBCT imaging	18 Years -	Maastricht Radiation Oncology
On-treatment Adaptation of Head and Neck Cancer Dosimetry Plans Using Novel Cone-beam CT and AI-driven Software	NCT05666193	Head and Neck C...	CBCT Imaging	19 Years -	Varian, a Siemens Healthineers Company

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