Evaluating the effect of 2D antiscatter grids on CBCT image quality

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

This study is testing whether using a special grid during CT scans can improve the quality of images for patients getting routine scans.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 2 sites (Aurora, Colorado and 1 other locations)
• Trial ID: NCT04565457 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the improvement in image quality provided by 2D antiscatter grid technology in cone beam computed tomography (CBCT). Participants will undergo scans with both a research CBCT system equipped with the antiscatter grid and a standard clinical CBCT as part of their routine care. The primary objective is to assess the enhancement in tissue visualization through a blinded observer study, comparing the two imaging methods. This single-arm approach allows for direct evaluation of the new technology's effectiveness in clinical settings.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 18-100 who are currently being treated with CBCT-guided photon therapy or image-guided proton therapy for specific cancers.

Not a fit: Patients with metallic implants in the scan volume or those unable to remain still during the imaging process may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved imaging quality for patients undergoing treatment for various cancers, enhancing treatment precision.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing imaging techniques, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Be a male or female aged 18-100.
4. 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.

Exclusion Criteria:

1. 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.
2. 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.
3. 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:

     1. 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 this trial is running

Aurora, Colorado and 1 other locations

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

Study contacts

• Principal investigator: Cem E Altunbas — University of Colorado, Denver
• Study coordinator: Kayla Vondran

Conditions Prostate Cancer; Head and Neck Cancers; Upper Abdomen Cancers