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

NCT05524454 | Completed Results FDA Device

• 1 other identifier: VAR-2022-04
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Breast Cancer; Abdominal Cancer; Pelvic Cancer; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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 Arms (1)

Novel CBCT Imaging

EXPERIMENTAL

All subjects undergo one additional imaging session with the novel CBCT imaging system.

Device: Novel CBCT Imaging

Interventions

Novel CBCT Imaging DEVICE

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

Novel CBCT Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient is pregnant

Sponsors & Collaborators

• Varian, a Siemens Healthineers Company: lead

Study Sites (1)

Maastricht Radiation Oncology

Maastricht, Limburg, 6229 ET 12, Netherlands

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms; Breast Neoplasms; Pelvic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Sean Davidson
• Organization: Varian Medical Systems

sean.davidson@varian.com

437-991-8294

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 1, 2022
• Study Start: March 20, 2023
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)