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

NCT ID: NCT04565457

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2025-05-28

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.

Conditions

Prostate Cancer; Head and Neck Cancers; Upper Abdomen Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants Scanned

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.

Group Type: EXPERIMENTAL

Research CBCT

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cem Altunbas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Aurora, Colorado, United States

University of Florida Health Proton Therapy Institute

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

R01CA245270

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-1684.cc

Identifier Type: -

Identifier Source: org_study_id