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

Completed · Not applicable

Conditions studied: Prostate Cancer, Head and Neck Cancers, Upper Abdomen Cancers

In brief

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.

Key facts

Study ID

NCT04565457

Run by

University of Colorado, Denver

People needed

43

Starts

2023-04-21

Expected to finish

2025-05-28

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision to sign and date the consent form.
• Stated willingness to comply with all study procedures and be available for the duration of the study.
• Be a male or female aged 18-100.
• Participants who will be treated or are currently being treated with CBCT-guided photon therapy for prostate or prostate-bed, abdomen head and neck, or pelvic cancers, or with image-guided proton therapy for prostate or prostate bed cancer.

You may not qualify if…

• Metallic implants in the CBCT scan volume, such as hip prostheses or spine stabilization hardware. Patients with pacemakers, defibrillators, or other implanted electronic devices. Dental implants, fillings, or fiducial markers may be acceptable, and the decision for inclusion/exclusion will be on a case-by-case basis, by reviewing prior CT images of the study candidate. Patient's prior CT images will be reviewed by the PI or the site PI.
• Patients who do not have the ability to lie still for the duration of his/her CBCT imaging and treatment should be excluded. If image artifacts in prior scans are deemed excessive, the patient will be excluded from the study.
• Known pregnancy. (Per SOC, a pregnancy test will be performed prior to CBCT scan on Day 1. At this time, women of child-bearing potential (WOCBP) will receive a pregnancy test to re-confirm eligibility).
• Women of child-bearing potential are described as:
• Age 55 or younger who have not had a negative pregnancy test within 3 days. This excludes patients who have had tubal ligation or are already post-menopausal.

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States
• University of Florida Health Proton Therapy Institute — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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