COMPLETED

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

Conditions

Prostate Cancer Head and Neck Cancers Upper Abdomen Cancers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-21

Study Completion:2025-05-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04565457

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Cem Altunbas, PhD

PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Study Locations (Sites)

University of Colorado Hospital

Aurora, Colorado, 80045

United States

University of Florida Health Proton Therapy Institute

Jacksonville, Florida, 32206

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Cem Altunbas, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-21

Study Completion Date2025-05-28

Study Record Updates

Study Start Date2023-04-21

Study Completion Date2025-05-28

Terms related to this study

Additional Relevant MeSH Terms

Prostate Cancer
Head and Neck Cancers
Upper Abdomen Cancers