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

Last updated: May 14, 2025
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Treatment

Research CBCT

Clinical Study ID

NCT04565457
20-1684.cc
R01CA245270
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision to sign and date the consent form.

  2. Stated willingness to comply with all study procedures and be available for theduration 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-guidedphoton therapy for prostate or prostate-bed, abdomen head and neck, or pelviccancers, or with image-guided proton therapy for prostate or prostate bed cancer.

Exclusion

Exclusion Criteria:

  1. Metallic implants in the CBCT scan volume, such as hip prostheses or spinestabilization hardware. Patients with pacemakers, defibrillators, or other implantedelectronic devices. Dental implants, fillings, or fiducial markers may beacceptable, and the decision for inclusion/exclusion will be on a case-by-casebasis, by reviewing prior CT images of the study candidate. Patient's prior CTimages 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 CBCTimaging and treatment should be excluded. If image artifacts in prior scans aredeemed excessive, the patient will be excluded from the study.

  3. Known pregnancy. (Per SOC, a pregnancy test will be performed prior to CBCT scan onDay 1. At this time, women of child-bearing potential (WOCBP) will receive apregnancy 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 3days. This excludes patients who have had tubal ligation or are alreadypost-menopausal.

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: Research CBCT
Phase:
Study Start date:
April 21, 2023
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • University of Colorado Health

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Florida Health Proton Therapy Institute

    Jacksonville, Florida 32206
    United States

    Active - Recruiting

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