NCT04565457

A Pilot Study Evaluating the Effect of 2D Antiscatter Grids on CBCT Image Quality

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is Pilot study that investigates the CBCT(Cone beam computed tomography) image quality improvement provided by the 2D antiscatter grid technology. The primary objective is to assess the improvement in tissue visualization in an observer study, which will be conducted in a blinded fashion.

Detailed description

This is a single arm study, where all participants will be scanned with a CBCT system equipped with 2D antiscatter grid technology, referred to as research CBCT. Each participant will also be scanned with a standard clinical CBCT as part of their standard clinical care, which will serve as the baseline, or control. Thus, the image quality improvement in research CBCT will assessed with respect to standard clinical CBCT.

Conditions

• Prostate Cancer
• Head and Neck Cancers
• Upper Abdomen Cancers

Interventions

Type	Name	Description
DEVICE	Research CBCT	Each study participant will receive one additional CBCT scan, with 2D antiscatter grid in place. This is the only intervention in the study, referred as research CBCT scan, and it will be performed on one of the days during the participant's radiation treatment course. This additional research CBCT scan will be used strictly for the objectives of this study. It will not be used as part of the standard clinical care, such as imaging guidance of participant's radiation treatment or diagnostic purposes. To deliver participant's radiation treatment under CBCT guidance, a standard clinical CBCT scan will be acquired, as in standard clinical care protocols.

Timeline

• Start date: 2023-04-21
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2020-09-25
• Last updated: 2025-11-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study