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 range18 Years – 100 Years

SexALL

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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.
✕. 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.
✕. 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).
✕. 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.

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 range18 Years – 100 Years

SexALL

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.
✕. 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.
✕. 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).
✕. 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.

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)