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Completed

NCT Number: NCT05524454

Evaluation of a Cone-beam CT Scanner for Image Guided Radiotherapy

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.

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Key information

Conditions

Head and Neck Cancer Abdominal Cancer Breast Cancer Breast Diseases Breast Neoplasms Head and Neck Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pelvic Cancer Pelvic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht Radiation Oncology

Maastricht, Limburg, 6229 ET 12, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient will be treated with external beam photon radiotherapy at Maastro for head-and-neck cancer, stage I lung cancer, stage II-IV lung cancer, left breast cancer, or tumours in the abdominal or pelvic region.
  • Age ≥ 18 years
  • Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician
  • Provision of written informed consent

Exclusion criteria

  • Patient is pregnant

Treatment and study plan

Novel CBCT Imaging

Device

One or two CBCT images are acquired on the novel CBCT imaging system.

Primary outcomes

  1. Image Quality

    Time frame: Within 1 month from the start of treatment

    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.

Secondary outcomes

  1. Accuracy of Radiation Dose Calculation on HyperSight CBCT

    Time frame: Within 1 month from the start of treatment

    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.

  2. Qualitative Assessment of Novel CBCT Images for Contouring Organs at Risk

    Time frame: Within 1 month from the start of treatment

    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.

Sponsors and collaborators

Lead sponsor

Varian, a Siemens Healthineers Company

Industry

Registry information

Official study title

Evaluation of a Cone-beam CT Scanner for Image Guided Radiotherapy (CONFIGURE)

Acronym: CONFIGURE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2022
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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