CompletedNot Applicable

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

United States43 participantsStarted 2023-04-21

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision to sign and date the consent form.
. Stated willingness to comply with all study procedures and be available for the duration of the study.
. Be a male or female aged 18-100.
. 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

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ratio of Standard CBCT to Research CBCT HU Error in Photon Therapy Participants

Timeframe: At time of CBCT imaging session (Day 1)

Median Shift in Hounsfield Unit (HU) Error Between Standard CBCT and Research CBCT in Proton Therapy Participants

Timeframe: At time of CBCT imaging session (Day 1)

Ratio of Artifact Amplitude Between Standard CBCT and Research CBCT in Photon Therapy Participants

Timeframe: At time of CBCT imaging session (Day 1)

Median Shift in Artifact Amplitude (Measured in Hounsfield Units) Between Standard CBCT and Research CBCT in Proton Therapy Participants

Timeframe: At time of CBCT imaging session (Day 1)

Ratio of Contrast-To-Noise Ratio (CNR) Between Standard CBCT and Research CBCT in Photon Therapy Participants

Timeframe: At time of CBCT imaging session (Day 1)

Median Shift in Contrast to Noise Ratio (CNR) Between Standard CBCT and Research CBCT in Proton Therapy Participants

Timeframe: At time of CBCT imaging session (Day 1)

Trial details

NCT IDNCT04565457

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-28

Results submitted2026-03-13

View on ClinicalTrials.gov More Prostate Cancer trials

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Provision to sign and date the consent form.
. Stated willingness to comply with all study procedures and be available for the duration of the study.
. Be a male or female aged 18-100.
. 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

. 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.

What they're measuring

Ratio of Standard CBCT to Research CBCT HU Error in Photon Therapy Participants

Timeframe: At time of CBCT imaging session (Day 1)

Median Shift in Hounsfield Unit (HU) Error Between Standard CBCT and Research CBCT in Proton Therapy Participants

Timeframe: At time of CBCT imaging session (Day 1)

Ratio of Artifact Amplitude Between Standard CBCT and Research CBCT in Photon Therapy Participants

Timeframe: At time of CBCT imaging session (Day 1)

Median Shift in Artifact Amplitude (Measured in Hounsfield Units) Between Standard CBCT and Research CBCT in Proton Therapy Participants

Timeframe: At time of CBCT imaging session (Day 1)

Ratio of Contrast-To-Noise Ratio (CNR) Between Standard CBCT and Research CBCT in Photon Therapy Participants

Timeframe: At time of CBCT imaging session (Day 1)

Median Shift in Contrast to Noise Ratio (CNR) Between Standard CBCT and Research CBCT in Proton Therapy Participants

Timeframe: At time of CBCT imaging session (Day 1)