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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04565457
• Other study ID #: 20-1684.cc
• Secondary ID: R01CA245270
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: Saralina Nguyen
• Phone: 720-848-0691
• Email: saraline.nguyen[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: September 30, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	University of Florida Health Proton Therapy Institute	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concordance Correlation Coefficients	Correlation of radiomics features in CBCT images and gold standard MDCT images, as measured by Concordance Correlation Coefficients (CCC).	4 years
Primary	Change in tissue visualization in CBCT images	Inter-observer similarity of delineated anatomical structures as measured by the Conformity Index (CI) similarity metrics.	4 years
Primary	Change in tissue visualization in CBCT images	Inter-observer similarity of delineated anatomical structures as measured by the Hausdorff distance (HD) similarity metrics.	4 years
Secondary	Comparison of tissue delineation in CBCT images by auto-segmentation software.	Similarity of anatomical structures delineated by autosegmentation software and expert observers, as measured by CI and HD metrics.	4 years