Head and Neck Cancers, Prostate Cancer, Upper Abdomen Cancers
Conditions
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.
Interventions
DEVICEResearch 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.
Sponsors
University of Colorado, Denver
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Standard CBCT to Research CBCT HU Error in Photon Therapy Participants | At time of CBCT imaging session (Day 1) | 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. |
| Median Shift in Hounsfield Unit (HU) Error Between Standard CBCT and Research CBCT in Proton Therapy Participants | At time of CBCT imaging session (Day 1) | 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. |
| Ratio of Artifact Amplitude Between Standard CBCT and Research CBCT in Photon Therapy Participants | At time of CBCT imaging session (Day 1) | 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. |
| Median Shift in Artifact Amplitude (Measured in Hounsfield Units) Between Standard CBCT and Research CBCT in Proton Therapy Participants | At time of CBCT imaging session (Day 1) | 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. |
| Ratio of Contrast-To-Noise Ratio (CNR) Between Standard CBCT and Research CBCT in Photon Therapy Participants | At time of CBCT imaging session (Day 1) | 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. |
| Median Shift in Contrast to Noise Ratio (CNR) Between Standard CBCT and Research CBCT in Proton Therapy Participants | At time of CBCT imaging session (Day 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Automated Tissue Delineation in CBCT Images for Photon Therapy Participants. Difference in Dice Similarity Coefficient Between Research CBCT and Standard CBCT | At time of CBCT imaging session. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCem Altunbas, PhD
University of Colorado, Denver
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Anatomical site Abdomen/Pelvis | 10 Participants |
| Anatomical site Head and Neck | 11 Participants |
| Anatomical site Prostate/Prostate bed | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 10 |
| other Total, other adverse events | 0 / 32 | 0 / 10 |
| serious Total, serious adverse events | 0 / 32 | 0 / 10 |
Outcome results
None listed