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

Not Applicable

Recruiting

• Conditions: Prostate Cancer; Head and Neck Cancers; Upper Abdomen Cancers
• Interventions: Device: Research CBCT

• Registration Number: NCT04565457
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Study Timeline

• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-25
• Study Start: 2023-04-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-04-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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 CBCT-guided proton therapy for prostate or prostate bed cancer.

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Exclusion Criteria

1. Metallic implants in the CBCT scan volume, such as hip prostheses or spine stabilization hardware. Dental implants, filings, 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.

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:

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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants Scanned	Research CBCT	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.

Primary Outcome Measures

Name	Time	Method
Change in tissue visualization in CBCT images	4 years	Inter-observer similarity of delineated anatomical structures as measured by the Hausdorff distance (HD) similarity metrics.

Secondary Outcome Measures

Name	Time	Method
Comparison of tissue delineation in CBCT images by auto-segmentation software.	4 years	Similarity of anatomical structures delineated by autosegmentation software and expert observers, as measured by CI and HD metrics.

Trial Locations

Locations (2)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

University of Florida Health Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States