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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 will examine the image quality generated by a new cone-beam CT (CBCT) imaging system integrated into an external beam radiation treatment delivery platform. Normally, CBCT images are acquired at the start of a daily radiation delivery treatment to align the patient with the images that were used to generate their radiation treatment plan. This alignment increases the precision of radiation delivery. This study will assess whether the improvements in image quality expected from the novel CBCT imaging system are sufficient for the images to be used for more than just patient alignment.
The study will enroll patients who will be treated with external beam radiation therapy for the following conditions: head and neck cancers, stage I lung cancer, stage II to IV lung cancer, cancer in the left breast, tumors in the abdomen, and tumors in the pelvic region. Each patient will undergo one additional imaging session with the novel CBCT imaging system during which 1 or 2 CBCT images will be acquired. The number of novel CBCT images acquired depends on the location and type of the patient's tumor. The additional imaging session will occur on the same day as one of the patient's scheduled treatment delivery sessions to minimize impact on the patient's schedule.
The patient's cancer treatment will not be affected by participation in this study. 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.
The images acquired by the novel CBCT imaging system will be compared to standard CBCT images acquired as part of the patient's treatment and to the CT simulation images used to define the patient's radiation treatment plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel CBCT Imaging | Experimental | All subjects undergo one additional imaging session with the novel CBCT imaging system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel CBCT Imaging | Device | One or two CBCT images are acquired on the novel CBCT imaging system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality | For this objective, the image noise level was evaluated in regions of interest representing different tissue types (muscle and fat) in both CT simulation images and HyperSight CBCT images. Image noise is the variation in image intensity, which is measured in Hounsfield Units (HU), in a region that should have uniform intensity without the presence of noise. Image noise is measured as the standard deviation of HU within the defined regions of interest. Higher noise values indicate poorer image quality. HyperSight images can be reconstructed from raw data using different reconstruction algorithms. For this analysis, both the standard Feldkamp-Davis-Kress (FDK) algorithm and an iterative metal artifact reduction (MAR) algorithm were evaluated. | Within 1 month from the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Radiation Dose Calculation on HyperSight CBCT | The accuracy of dose calculation on HyperSight CBCT was evaluated by re-calculating a participant's clinical treatment plan on one of their HyperSight images and comparing the doses delivered to target structures and organs at risk (OARs). The lower the difference in dose metrics between a HyperSight CBCT-based plan and a CT simulation-based plan, the more accurate the dose calculation on HyperSight CBCT. Both the maximum dose delivered to OARs and the mean dose delivered to OARs were compared between HyperSight-based plans and CT simulation-based plans. We report the worst overall accuracy, i.e. maximum difference in dose metrics across all OARs from across all patients. Similarly, the maximum dose delivered to the target, the mean dose delivered to the target and the minimum dose delivered to 95% of the target were compared between HyperSight CBCT-based plans and CT simulation-based plans. We report here the maximum difference across all dose metrics from across all patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht Radiation Oncology | Maastricht | Limburg | 6229 ET 12 | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Novel CBCT Imaging | All subjects undergo one additional imaging session with the novel CBCT imaging system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are provided for study participants who had study imaging performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Novel CBCT Imaging | All subjects undergo one additional imaging session with the novel CBCT imaging system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Image Quality | For this objective, the image noise level was evaluated in regions of interest representing different tissue types (muscle and fat) in both CT simulation images and HyperSight CBCT images. Image noise is the variation in image intensity, which is measured in Hounsfield Units (HU), in a region that should have uniform intensity without the presence of noise. Image noise is measured as the standard deviation of HU within the defined regions of interest. Higher noise values indicate poorer image quality. HyperSight images can be reconstructed from raw data using different reconstruction algorithms. For this analysis, both the standard Feldkamp-Davis-Kress (FDK) algorithm and an iterative metal artifact reduction (MAR) algorithm were evaluated. | Images were analyzed according to the anatomical region being imaged. As of the last date of publication to ClinicalTrials.gov, only data for the 7 Head/Neck participants were available. | Posted | Median | Full Range | standard deviation of HU values | Within 1 month from the start of treatment |
|
Adverse events were recorded from the time a subject consented to participate in the study to the end of their radiation therapy treatment, or to the end of their participation in the study, whichever came first. The adverse event assessment period typically was from 2-6 weeks, depending on the duration of the participant's radiation treatment.
Only adverse events that were Possibly, Probably, or Definitely attributable to HyperSight imaging were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Novel CBCT Imaging | All subjects undergo one additional imaging session with the novel CBCT imaging system. Novel CBCT Imaging: One or two CBCT images are acquired on the novel CBCT imaging system. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean Davidson | Varian Medical Systems | 437-991-8294 | sean.davidson@varian.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2023 | May 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D010386 | Pelvic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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This is a single-site study designed to generate data describing the quality and applicability of a novel on-couch CBCT imaging system for anatomy visualization and radiation treatment dosimetry planning.
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| Within 1 month from the start of treatment |
| Qualitative Assessment of Novel CBCT Images for Contouring Organs at Risk | CT simulation images and HyperSight CBCTs from subjects were randomly presented to expert reviewers, who were blinded to the type of image they were looking at and who were asked to rate their confidence level for contouring organs at risk (OARs) on the images using a 5-point Likert scale (very high, high, moderate, low, very low). The percentage of times that a reviewer rated their confidence level for contouring OARs on HyperSight CBCT as moderate, high, or very high was recorded. A higher percentage means a more favorable assessment for OAR contouring on HyperSight CBCT. The percentage of times the reviewer's confidence level for contouring on a HyperSight CBCT was equal to or higher than their confidence level on the corresponding CT simulation image was also recorded, where again a higher percentage means a better assessment for OAR contouring on HyperSight CBCT. The HyperSight iterative metal artifact reconstruction (MAR) algorithm was used in this analysis. | Within 1 month from the start of treatment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Height and/or weight values were not available for 2 study participants. | Mean | Full Range | kg/m^2 |
|
| OG000 |
| Head/Neck Imaging |
Evaluation of images of study participants treated for head/neck cancer. |
|
|
| Secondary | Accuracy of Radiation Dose Calculation on HyperSight CBCT | The accuracy of dose calculation on HyperSight CBCT was evaluated by re-calculating a participant's clinical treatment plan on one of their HyperSight images and comparing the doses delivered to target structures and organs at risk (OARs). The lower the difference in dose metrics between a HyperSight CBCT-based plan and a CT simulation-based plan, the more accurate the dose calculation on HyperSight CBCT. Both the maximum dose delivered to OARs and the mean dose delivered to OARs were compared between HyperSight-based plans and CT simulation-based plans. We report the worst overall accuracy, i.e. maximum difference in dose metrics across all OARs from across all patients. Similarly, the maximum dose delivered to the target, the mean dose delivered to the target and the minimum dose delivered to 95% of the target were compared between HyperSight CBCT-based plans and CT simulation-based plans. We report here the maximum difference across all dose metrics from across all patients. | Dose calculation accuracy was analyzed according to the anatomical region being imaged. As of the last date of publication to ClinicalTrials.gov, only data for the 7 Head/Neck participants were available. | Posted | Number | Gy | Within 1 month from the start of treatment |
|
|
|
| Secondary | Qualitative Assessment of Novel CBCT Images for Contouring Organs at Risk | CT simulation images and HyperSight CBCTs from subjects were randomly presented to expert reviewers, who were blinded to the type of image they were looking at and who were asked to rate their confidence level for contouring organs at risk (OARs) on the images using a 5-point Likert scale (very high, high, moderate, low, very low). The percentage of times that a reviewer rated their confidence level for contouring OARs on HyperSight CBCT as moderate, high, or very high was recorded. A higher percentage means a more favorable assessment for OAR contouring on HyperSight CBCT. The percentage of times the reviewer's confidence level for contouring on a HyperSight CBCT was equal to or higher than their confidence level on the corresponding CT simulation image was also recorded, where again a higher percentage means a better assessment for OAR contouring on HyperSight CBCT. The HyperSight iterative metal artifact reconstruction (MAR) algorithm was used in this analysis. | Images were assessed according to the anatomical region being imaged. As of the last date of publication to ClinicalTrials.gov, only data for the 7 Head/Neck participants were available. Seven observers evaluated two image series - CT simulation images and HyperSight CBCT - from each study participant. | Posted | Number | % evaluations | Within 1 month from the start of treatment | Evaluations | Evaluations |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |