Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA245270 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Scanned | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Research CBCT | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Standard CBCT to Research CBCT HU Error in Photon Therapy Participants | Ratio of HU error for standard clinical CBCT (iteratively reconstructed) relative to research CBCT with 2D antiscatter grid in photon therapy participants. HU error was assessed in corresponding regions of interest, and the ratio was estimated using a linear mixed-effects model. A ratio greater than 1 would indicate higher HU error in standard CBCT than in research CBCT. A ratio less than 1 would indicate higher HU error in research CBCT than in standard CBCT. | 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 | Median paired shift in Hounsfield Unit (HU) error between research CBCT and standard clinical CBCT scans in participants receiving proton radiation therapy. HU error was evaluated in corresponding regions of interest in paired scans. The Hodges-Lehmann estimate of the median shift and its 95% confidence interval were calculated, and paired differences were evaluated using a Wilcoxon signed-rank test. | At time of CBCT imaging session (Day 1) |
| Ratio of Artifact Amplitude Between Standard CBCT and Research CBCT in Photon Therapy Participants | Ratio of artifact amplitude between standard clinical CBCT (iteratively reconstructed) and research CBCT scans in participants receiving photon radiation therapy. Artifact amplitude was measured in corresponding regions of interest. The ratio of artifact amplitude between standard CBCT and research CBCT was estimated using a linear mixed-effects model. Ratio greater than 1 would indicate that standard CBCT has greater artifact amplitude than research CBCT. | 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 | Median paired shift in Artifact Amplitude between research CBCT and standard clinical CBCT scans in participants receiving proton radiation therapy. Artifact Amplitude error was evaluated in corresponding regions of interest in paired scans. The Hodges-Lehmann estimate of the median shift and its 95% confidence interval were calculated, and paired differences were evaluated using a Wilcoxon signed-rank test. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Automated Tissue Delineation in CBCT Images for Photon Therapy Participants. Difference in Dice Similarity Coefficient Between Research CBCT and Standard CBCT | Similarity between anatomical structures delineated by auto-segmentation software and expert observer contours in research CBCT and standard clinical CBCT images was evaluated using the Dice similarity coefficient. The pairwise difference in Dice coefficients between standard clinical CBCT and research CBCT images was calculated. Higher Dice coefficients indicate greater similarity between auto-segmented and expert-drawn contours and higher accuracy in automated tissue delineation. |
Not provided
Inclusion Criteria:
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).
Women of child-bearing potential are described as:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cem Altunbas, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States | ||
| University of Florida Health Proton Therapy Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Out of 43 participants enrolled in the study, 42 were scanned with the research and the standard CBCT protocol. One participant in the proton therapy arm withdrew from the study before the research CBCT scan. 32 participants received photon and 10 participants received proton therapy. Outcomes of each therapy cohort was analyzed separately in two separate arms.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Photon Therapy Participants | All photon radiotherapy participants were scanned with a CBCT system installed on a linac equipped with 2D antiscatter grid technology, referred to as research CBCT. Each participant was also scanned with a standard clinical CBCT as part of their standard clinical care, which served as the baseline, or control. |
| FG001 | Proton Therapy Participants | All proton radiotherapy participants were scanned with a CBCT system installed on a proton therapy gantry equipped with 2D antiscatter grid technology, referred to as research CBCT. Each participant was also scanned with a standard clinical CBCT as part of their standard clinical care, which served as the baseline, or control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Total of 32 participants were enrolled and scanned in the photon therapy arm. One of the participant in the photon therapy arm scan was excluded from the analysis due to a technical issue during the CBCT scan.
In the proton therapy arm, all 10 participants who were scanned with research CBCT were included in the analysis. Therefore, baseline characteristics are reported for total of 41 participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Photon Therapy Participants | Participants receiving photon radiation therapy, scanned with a novel CBCT technique, referred to as "Research CBCT". Each participant scanned twice, once with the research CBCT method under investigation and once with the standard of care CBCT. The novel Research CBCT technique incorporates a 2D antiscatter grid device. Patients were accrued based on their treatment site: prostate/prostate bed, abdomen/pelvis, head and neck (H&N). . |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Forty-three participants were enrolled. One participant withdrew from the study before the intervention. Total of 42 participants were scanned. One of the participants scan was excluded from the analysis due to a technical issue during the CBCT scan. Therefore, baseline characteristics are reported for 41 participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Accuracy of Automated Tissue Delineation in CBCT Images for Photon Therapy Participants. Difference in Dice Similarity Coefficient Between Research CBCT and Standard CBCT | Similarity between anatomical structures delineated by auto-segmentation software and expert observer contours in research CBCT and standard clinical CBCT images was evaluated using the Dice similarity coefficient. The pairwise difference in Dice coefficients between standard clinical CBCT and research CBCT images was calculated. Higher Dice coefficients indicate greater similarity between auto-segmented and expert-drawn contours and higher accuracy in automated tissue delineation. | 31 photon therapy participants were enrolled. Five participants were excluded from the secondary outcome analysis because the required segmentation data were not suitable for analysis due to severe artifacts in the CBCT images. Mean difference in Dice similarity coefficient (standard CBCT minus research CBCT) was analyzed. Negative values would indicate higher Dice similarity and auto-delineation accuracy for research CBCT. | Posted | Mean | 95% Confidence Interval | Difference in Dice coefficients | At time of CBCT imaging session. |
From enrollment until the completion of research CBCT scan
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Photon Therapy Participants | All photon therapy participants were scanned with a CBCT system mounted on a C-arm linac. |
Not provided
Not provided
Research CBCT scans were performed while participants were free breathing. When organ motion was present in the scan volume, image artifacts caused by motion might have affected the values of image quality metrics in both research and standard of care CBCT scans.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cem Altunbas, PhD | University of Colorado Cancer Center | 7208480098 | cem.altunbas@cuanschutz.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2024 | Mar 9, 2026 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Single arm study
Not provided
Not provided
Not provided
Not provided
|
| 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 | Ratio of CNR between standard clinical CBCT and research CBCT scans in participants receiving photon radiation therapy. CNR was quantified in corresponding regions of interest in paired standard and research CBCT scans of each participant. The ratio of CNR between standard CBCT and research CBCT was estimated using a linear mixed-effects model. | 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 | Median paired shift in CNR between research CBCT and standard clinical CBCT scans in participants receiving proton radiation therapy. CNR was evaluated in corresponding regions of interest in paired scans. The Hodges-Lehmann estimate of the median shift and its 95% confidence interval were calculated, and paired differences were evaluated using a Wilcoxon signed-rank test. | At time of CBCT imaging session (Day 1) |
| At time of CBCT imaging session. |
| Jacksonville |
| Florida |
| 32206 |
| United States |
| BG001 | Proton Therapy Participants | Participants receiving proton radiation therapy scanned with a novel CBCT technique, referred to as "Research CBCT". Each participant scanned twice, once with the research CBCT method under investigation and once with the standard of care CBCT. The novel Research CBCT technique incorporates a 2D antiscatter grid device. Proton therapy patients treated for prostate or prostate bed cancers were accrued. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | A sex-specific analysis was not done. | Forty-three participants were enrolled. One participant withdrew from the study before the intervention. Total of 42 participants were scanned. One of the participants scan was excluded from the analysis due to a technical issue during the CBCT scan. Therefore, baseline characteristics are reported for 41 participants. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race distribution | Forty-three participants were enrolled. One participant withdrew from the study before the intervention. Total of 42 participants were scanned. One of the participants scan was excluded from the analysis due to a technical issue during the CBCT scan. Therefore, baseline characteristics are reported for 41 participants. | Count of Participants | Participants | No |
|
| Anatomical site | Anatomical site of radiation therapy treatment for enrolled participants (e.g., prostate/prostate bed, abdomen/pelvis, head and neck). | In the proton therapy arm, only prostate or prostate bed cancer patients were accrued. In the photon therapy arm, patients with the following treatment sites were accrued: Prostate/prostate bed cancers, H&N cancer, and pelvic/abdominal cancers. | Number | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Photon Therapy Participants | All photon radiotherapy participants will be scanned using the Research CBCT technique. 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. |
|
|
|
| Primary | Ratio of Standard CBCT to Research CBCT HU Error in Photon Therapy Participants | Ratio of HU error for standard clinical CBCT (iteratively reconstructed) relative to research CBCT with 2D antiscatter grid in photon therapy participants. HU error was assessed in corresponding regions of interest, and the ratio was estimated using a linear mixed-effects model. A ratio greater than 1 would indicate higher HU error in standard CBCT than in research CBCT. A ratio less than 1 would indicate higher HU error in research CBCT than in standard CBCT. | Out of 32 participants in the photon therapy group, 31 participants with evaluable paired CBCT scans (research CBCT with 2D antiscatter grid and standard clinical CBCT) were included in this analysis. One participant was excluded due to non-evaluable imaging data caused by a CBCT technical problem during the CBC T scan. | Posted | Mean | 95% Confidence Interval | Ratio (unitless) | At time of CBCT imaging session (Day 1) |
|
|
|
|
| Primary | Median Shift in Hounsfield Unit (HU) Error Between Standard CBCT and Research CBCT in Proton Therapy Participants | Median paired shift in Hounsfield Unit (HU) error between research CBCT and standard clinical CBCT scans in participants receiving proton radiation therapy. HU error was evaluated in corresponding regions of interest in paired scans. The Hodges-Lehmann estimate of the median shift and its 95% confidence interval were calculated, and paired differences were evaluated using a Wilcoxon signed-rank test. | Proton therapy participants with standard CBCT and research CBCT scans were included in this analysis. All 10 participants in this arm were included in the analysis. | Posted | Median | 95% Confidence Interval | Change in HU error | At time of CBCT imaging session (Day 1) |
|
|
|
|
| Primary | Ratio of Artifact Amplitude Between Standard CBCT and Research CBCT in Photon Therapy Participants | Ratio of artifact amplitude between standard clinical CBCT (iteratively reconstructed) and research CBCT scans in participants receiving photon radiation therapy. Artifact amplitude was measured in corresponding regions of interest. The ratio of artifact amplitude between standard CBCT and research CBCT was estimated using a linear mixed-effects model. Ratio greater than 1 would indicate that standard CBCT has greater artifact amplitude than research CBCT. | 31 participants with evaluable paired CBCT scans (research CBCT with 2D antiscatter grid and standard clinical CBCT) were included in this analysis. | Posted | Mean | 95% Confidence Interval | Ratio | At time of CBCT imaging session (Day 1) |
|
|
|
|
| Primary | Median Shift in Artifact Amplitude (Measured in Hounsfield Units) Between Standard CBCT and Research CBCT in Proton Therapy Participants | Median paired shift in Artifact Amplitude between research CBCT and standard clinical CBCT scans in participants receiving proton radiation therapy. Artifact Amplitude error was evaluated in corresponding regions of interest in paired scans. The Hodges-Lehmann estimate of the median shift and its 95% confidence interval were calculated, and paired differences were evaluated using a Wilcoxon signed-rank test. | All 10 proton therapy participants with paired standard CBCT and research CBCT scans were included in this analysis. | Posted | Median | 95% Confidence Interval | Change in HU | At time of CBCT imaging session (Day 1) |
|
|
|
|
| Primary | Ratio of Contrast-To-Noise Ratio (CNR) Between Standard CBCT and Research CBCT in Photon Therapy Participants | Ratio of CNR between standard clinical CBCT and research CBCT scans in participants receiving photon radiation therapy. CNR was quantified in corresponding regions of interest in paired standard and research CBCT scans of each participant. The ratio of CNR between standard CBCT and research CBCT was estimated using a linear mixed-effects model. | 31 participants with evaluable paired CBCT scans (research CBCT with 2D antiscatter grid and standard clinical CBCT) were included in this analysis. | Posted | Mean | 95% Confidence Interval | Ratio | At time of CBCT imaging session (Day 1) |
|
|
|
|
| Primary | Median Shift in Contrast to Noise Ratio (CNR) Between Standard CBCT and Research CBCT in Proton Therapy Participants | Median paired shift in CNR between research CBCT and standard clinical CBCT scans in participants receiving proton radiation therapy. CNR was evaluated in corresponding regions of interest in paired scans. The Hodges-Lehmann estimate of the median shift and its 95% confidence interval were calculated, and paired differences were evaluated using a Wilcoxon signed-rank test. | Proton therapy participants were included in this analysis. Data of 10 participants were analyzed. | Posted | Median | 95% Confidence Interval | Unitless | At time of CBCT imaging session (Day 1) |
|
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Proton Therapy Participants | All proton therapy participants were scanned with a CBCT system mounted on a proton therapy gantry. | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Superiority |
For photon therapy participants, the ratio of HU errors between standard CBCT and research CBCT was estimated using a linear mixed-effects model. All outcomes were log transformed (natural logarithms) for the validity of normality. Tukey correction were used to control the family-wise error rate at 0.05. |
| Superiority |
The p-value corresponds to the Wilcoxon signed-rank test for paired differences in HU error between standard CBCT and research CBCT. |
Superiority was defined as lower artifact amplitude in research CBCT relative to standard CBCT. For example, a ratio less than 1 would indicate lower artifact amplitude in research CBCT compared to standard CBCT. |
| Superiority |
Superiority was defined as lower artifact amplitude in research CBCT compared with standard CBCT. The Hodges-Lehmann estimate represents the median paired shift in artifact amplitude between standard CBCT and research CBCT. Negative values would indicate lower artifact amplitude in research CBCT. |