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Clinical Trials/NCT05524454
NCT05524454
Completed
Not Applicable

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

Varian, a Siemens Healthineers Company1 site in 1 country41 target enrollmentMarch 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Varian, a Siemens Healthineers Company
Enrollment
41
Locations
1
Primary Endpoint
Image Quality
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 20, 2023
End Date
August 18, 2023
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Varian, a Siemens Healthineers Company
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Accuracy of Radiation Dose Calculation on HyperSight CBCT(Within 1 month from the start of treatment)
  • Qualitative Assessment of Novel CBCT Images for Contouring Organs at Risk(Within 1 month from the start of treatment)

Study Sites (1)

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