Lung CancerNCT05176860
Evaluation of Novel Cone-Beam CT for Guidance and Adaptation of Precision Radiotherapy
A study testing CBCT Imaging in people with Lung Cancer and Liver Cancer, run by Varian, a Siemens Healthineers Company at 1 site in Canada.
Trial summary
This is a feasibility study investigating the image quality of a new, high-performance cone beam CT (CBCT) used for on-couch imaging during radiotherapy treatments. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lung Cancer, Liver Cancer, Breast Cancer
- What is being tested?
- CBCT Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 20 Dec 2022to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is scheduled for treatment on one of the five TrueBeam platforms at the NS Health QE2 site.
- Subject is receiving radiation therapy using a breath-hold technique (for example, lung, liver and left breast cancers).
Who cannot join
- Patient is pregnant or has plans for pregnancy during the period of treatment.
- Patient is unwilling to consent to participating to the study, or for whom informed consent is not possible.
Trial locations and contacts
1 site in 1 country.
About this study
This is a feasibility study investigating the image quality of a new, high-performance cone beam CT (CBCT) used for on-couch imaging during radiotherapy treatments.
Read the detailed description
This study focuses on potential benefits of a high performance cone beam CT (CBCT) image guidance system for improved precision in the delivery of radiotherapy. CBCT is currently used during radiation therapy to align the patient to their original treatment plan to increase the precision of radiation delivery. Current CBCT imaging technology requires approximately a minute to acquire an image. In order to acquire images with sufficient quality to allow accurate targeting, the patient may need to perform multiple breath hold maneuvers to "freeze" the motion of tumors that move with the breathing cycle (e.g. lung, liver, and breast tumors). The new high-performance CBCT can acquire an image in approximately 6 seconds, potentially enabling acquisition of images with a single breath hold. Improved motion compensation algorithms used in image reconstruction may allow acquisition of good quality images even while a patient is not holding their breath.
The methodology for the subject's treatment setup, CT simulation, treatment planning, image guidance and treatment delivery will be determined by the subject's treatment team and is not specified by this study. Enrollment in the study may occur after treatment delivery has started but must be prior to the fifth fraction.
Following completion of informed consent to participate in this study, high-performance CBCT imaging will be scheduled immediately before or after one of the subject's first five scheduled radiation treatment fractions. Two research CBCT images will be acquired, one with breath hold, the other with free breathing.
With minimal disruption for participating patients, this study will enable a comparison of (i) the subject's treatment planning fan-beam CT and (ii) the conventional CBCT acquired on an existing treatment unit with (iii) the high-performance CBCT. Image quality of the high performance CBCT image data will thereby be compared to both a best-case standard (fan-beam) and the status-quo for on-couch imaging to isolate and identify improvements.
- Conditions
- Lung Cancer, Liver Cancer, Breast Cancer, Other Cancer
- Being tested
- CBCT Imaging
- Medical subject headings
- Lung Neoplasms, Liver Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT ImagingDevice
Two research CBCT images will be acquired per subject.
| Study group | Role | What they receive |
|---|---|---|
| High-performance CBCT imaging | Experimental | Two additional study imaging sets are acquired. Receives: Device: CBCT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBCT Image Quality - Artifact Index
Artifact Index (AI) is a measurement of the strength of imaging artifact and the degree to which is affects visibility of anatomical structures in the vicinity of the artifact. Artifacts can be produced in CT and CBCT images by a number of factors, such as metal implants, gas, or breathing motion.
AI = sqrt((STD_VOI)^2 - (STD_background)^2),
where STD_VOI is the standard deviation of the image Hounsfield Units in a region of interest at the location of an artifact, and STD_background is the standard deviation of the Hounsfield Unit values in the background (i.e. in similar tissue but away from the artifact.
A lower AI value indicates that the artifact has a lower impact on image quality. Artifacts were identified in all study participants. The median AI across the study population is presented for four imaging modalities.
Measured: 1 day
CBCT Image Quality - Image Nonuniformity
Nonuniformity (NU) is a measure of the variation of CT image intensity in uniform tissue.
NU = (HU_max - HU_min)/(HU_max + HU_min),
where HU_max and HU_min are the maximum and minimum Hounsfield Unit values among multiple locations sampled within regions of uniform tissue that were relevant to the anatomy of interest (e.g., a uniform region of breast tissue for patients undergoing breast treatments).
A lower NU represents greater uniformity of CT image intensity within a region of interest. Median NU across the study population is presented for four imaging modalities.
Measured: 1 day
CBCT Image Quality - Contrast
Contrast represents the ability to distinguish between two different regions in a CT image (e.g. to distinguish between two adjacent organs).
Contrast = |HU1 - HU2|
where HU1 and HU2 are the mean HU values in two different 100 mm^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments).
Higher contrast values indicate that it is easier to distinguish between regions (anatomical structures) in a CT image. Median contrast across the study population is presented for four imaging modalities.
Measured: 1 week
CBCT Image Quality - Contrast to Noise Ratio
Contrast to Noise Ratio (CNR) measures the ability to distinguish an object or lesion from its background.
CNR = |HU1 - HU2|/[0.5 (STD1 + STD2)]
where HU1 and HU2 are the mean Hounsfield Unit values in two different 100 mm^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments), and STD1 and STD2 are the standard deviations of the HU values in those same ROIs.
A higher CNR makes it easier to distinguish an object from its background. CNR analysis was limited to images with similar imaging dose. Median CNR across all study participants treated for lung cancer are presented for three CBCT modalities.
Measured: 1 week
CBCT Image Quality - HU Similarity to CT Simulation
The intensity of a pixel in a CT image is a function of its Hounsfield Unit (HU) value. HU is also directly related to the underlying electron density, which means that the pixel value of a CT image can be used directly in the calculation of dose for a prescribed radiation treatment plan. CT simulation scanners produce images with high HU accuracy and are regularly used for radiation treatment planning. Here, we present the difference in HU between CT simulation images and different CBCT images.
ΔHU = HU_CBCT - HU_CTSim,
where HU_CBCT and HU_CTSim are mean values among HU averages at 4 reference points in a CBCT image and the corresponding CT simulation image, respectively.
The lower the ΔHU, the greater the HU accuracy of the CBCT image, and the greater the likelihood that CBCT imaging can be used for radiation treatment planning. Median ΔHU across the study population are presented for three different tissue types for three CBCT imaging modalities.
Measured: 1 week
Secondary outcomes (12)
Dosimetry Calculations - Gamma Pass Rate
Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. The overall difference between calculated radiation distributions was evaluated using three different gamma pass criteria: 3% dose difference / 3 mm distance to agreement, 2%/2mm, and 1%/1mm. The gamma pass rate is expressed as a percentage of data points that meet the pass criteria. A gamma pass rate of > 95% is typically considered acceptable for 3%/3mm. As the gamma pass criteria become stricter, the pass rates decrease. Gamma pass rates were calculated to compare the CT simulation-based dose calculation and the high performance CBCT-based dose calculation. Gamma pass rates were also calculated to compare the CT simulation-based dose calculation and the conventional CBCT-based dose calculation. The median gamma pass rates across the entire study population are presented.
Measured: 1 day
Dosimetry Calculations - Target DVH Volume Metrics
Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual target structures from all three dose distributions. Individual DVH metrics, such as V90(%) (the percentage of the structure volume receiving 90% of the prescribed radiation dose) were extracted for individual target structures from their DVH. The difference between a DVH metric derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median target DVH metric differences across the study population are presented.
Measured: 1 day
Dosimetry Calculations - Target DVH Dose Metrics
Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual target structures from all three dose distributions. Individual DVH dose metrics, such as D95(%) (the minimum dose covering 95% of the structure, expressed as a % of the prescription dose) were extracted for individual target structures from their DVH. The difference between a DVH metric derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median target DVH metric differences across the study population are presented.
Measured: 1 day
Dosimetry Calculations - Breast OAR DVH Metrics
Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions. The key organs at risk for patients being treated for breast cancer are the heart, ipsilateral lung, and contralateral breast. The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median differences in OAR D2%(%) across study participants treated for breast cancer are presented.
Measured: 1 day
Dosimetry Calculations - Lung OAR DVH Metrics
Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions. The key organs at risk for patients being treated for lung cancer are the heart, esophagus and spinal cord. The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median differences in OAR D2%(%) across study participants treated for lung cancer are presented.
Measured: 1 day
Dosimetry Calculations - Abdomen OAR DVH Metrics
Every trial participant had a radiation treatment plan calculated on their CT simulation image series. That same plan was then re-calculated on both the breath hold high-performance CBCT and conventional CBCT. Dose-volume histograms (DVH) were calculated for individual organs at risk (OAR) from all three dose distributions. The key organs at risk for patients being treated for abdominal cancer are the heart, bowel and kidneys. The differences between the D2%(%) (minimum dose received by the "hottest" 2% of the OAR, expressed as a % of the prescription dose) derived from CT simulation-based dose calculation and the same metric derived from a CBCT-based dose calculation are reported. The smaller the difference, the greater the accuracy of the CBCT-based dose calculation. Median differences in OAR D2%(%) across study participants treated for abdominal cancer are presented.
Measured: 1 day
Patient Experience - General Ease of Breath Hold
Study participants were asked to respond to the statement, "I find it easy to hold my breath", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
Measured: 1 Day
Patient Experience - Ease of Breath Hold on TrueBeam
Study participants were asked to respond to the statement, "It was easy for me to perform the breath holds that were needed for imaging on the TrueBeam radiation machine", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
Measured: 1 Day
Patient Experience - Ease of Breath Hold on Ethos
Study participants were asked to respond to the statement, "It was easy for me to perform the breath holds needed for imaging on the Ethos radiation machine", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
Measured: 1 Day
Patient Experience - Relative Ease of Breath Hold Between Machines
Study participants were asked to respond to the statement, "It was easier for me to perform the breath holds needed for imaging on one radiation machine compared to the other", on a 5-point scale, where 1 represents "TrueBeam much easier", 3 represents "Both machines equally easy", and 5 represents "Ethos much easier".
Measured: 1 Day
Patient Experience - Overall TrueBeam Experience
Study participants were asked to respond to the statement, "My overall experience during imaging on the TrueBeam was good", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
Measured: 1 Day
Patient Experience - Overall Ethos Experience
Study participants were asked to respond to the statement, "My overall experience during imaging on the Ethos platform was good", on a 5-point scale, where 1 represents "Strongly Disagree", 3 represents "Neutral", and 5 represents "Strongly Agree".
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start20 Dec 2022
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Varian, a Siemens Healthineers CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-site study designed to generate data describing the quality and applicability of on-couch high-performance CBCT imaging for anatomy visualization and radiation treatment dosimetry planning.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176860
- Sponsor's protocol ID
- VAR-2021-12
- Status last verified
- Aug 2026
- First submitted
- 16 Dec 2021
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Cone-Beam CT for Guidance and Adaptation of Precision Radiotherapy
- ClinicalTrials.gov ID
- NCT05176860
- Acronym / sponsor ID
- VAR-2021-12
- Conditions
- Lung Cancer, Liver Cancer, Breast Cancer, Other Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Posted 6 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility study investigating the image quality of a new, high-performance cone beam CT (CBCT) used for on-couch imaging during radiotherapy treatments.
Detailed description
This study focuses on potential benefits of a high performance cone beam CT (CBCT) image guidance system for improved precision in the delivery of radiotherapy. CBCT is currently used during radiation therapy to align the patient to their original treatment plan to increase the precision of radiation delivery. Current CBCT imaging technology requires approximately a minute to acquire an image. In order to acquire images with sufficient quality to allow accurate targeting, the patient may need to perform multiple breath hold maneuvers to "freeze" the motion of tumors that move with the breathing cycle (e.g. lung, liver, and breast tumors). The new high-performance CBCT can acquire an image in approximately 6 seconds, potentially enabling acquisition of images with a single breath hold. Improved motion compensation algorithms used in image reconstruction may allow acquisition of good quality images even while a patient is not holding their breath.
The methodology for the subject's treatment setup, CT simulation, treatment planning, image guidance and treatment delivery will be determined by the subject's treatment team and is not specified by this study. Enrollment in the study may occur after treatment delivery has started but must be prior to the fifth fraction.
Following completion of informed consent to participate in this study, high-performance CBCT imaging will be scheduled immediately before or after one of the subject's first five scheduled radiation treatment fractions. Two research CBCT images will be acquired, one with breath hold, the other with free breathing.
With minimal disruption for participating patients, this study will enable a comparison of (i) the subject's treatment planning fan-beam CT and (ii) the conventional CBCT acquired on an existing treatment unit with (iii) the high-performance CBCT. Image quality of the high performance CBCT image data will thereby be compared to both a best-case standard (fan-beam) and the status-quo for on-couch imaging to isolate and identify improvements.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-site study designed to generate data describing the quality and applicability of on-couch high-performance CBCT imaging for anatomy visualization and radiation treatment dosimetry planning.
| Arm | Type | Receives |
|---|---|---|
| High-performance CBCT imaging | Experimental | Device: CBCT ImagingTwo additional study imaging sets are acquired. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is scheduled for treatment on one of the five TrueBeam platforms at the NS Health QE2 site.
- Subject is receiving radiation therapy using a breath-hold technique (for example, lung, liver and left breast cancers).
Key exclusion criteria (2 listed)
- Patient is pregnant or has plans for pregnancy during the period of treatment.
- Patient is unwilling to consent to participating to the study, or for whom informed consent is not possible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBCT ImagingTwo research CBCT images will be acquired per subject. | Device | High-performance CBCT imaging |
Primary outcome
CBCT Image Quality - Artifact Index
Time frame: 1 day
Artifact Index (AI) is a measurement of the strength of imaging artifact and the degree to which is affects visibility of anatomical structures in the vicinity of the artifact. Artifacts can be produced in CT and CBCT images by a number of factors, such as metal implants, gas, or breathing motion. AI = sqrt((STD_VOI)^2 - (STD_background)^2), where STD_VOI is the standard deviation of the image Hounsfield Units in a region of interest at the location of an artifact, and STD_background is the standard deviation of the Hounsfield Unit values in the background (i.e. in similar tissue but away from the artifact. A lower AI value indicates that the artifact has a lower impact on image quality. Artifacts were identified in all study participants. The median AI across the study population is presented for four imaging modalities.
CBCT Image Quality - Image Nonuniformity
Time frame: 1 day
Nonuniformity (NU) is a measure of the variation of CT image intensity in uniform tissue. NU = (HU_max - HU_min)/(HU_max + HU_min), where HU_max and HU_min are the maximum and minimum Hounsfield Unit values among multiple locations sampled within regions of uniform tissue that were relevant to the anatomy of interest (e.g., a uniform region of breast tissue for patients undergoing breast treatments). A lower NU represents greater uniformity of CT image intensity within a region of interest. Median NU across the study population is presented for four imaging modalities.
CBCT Image Quality - Contrast
Time frame: 1 week
Contrast represents the ability to distinguish between two different regions in a CT image (e.g. to distinguish between two adjacent organs). Contrast = |HU1 - HU2| where HU1 and HU2 are the mean HU values in two different 100 mm^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments). Higher contrast values indicate that it is easier to distinguish between regions (anatomical structures) in a CT image. Median contrast across the study population is presented for four imaging modalities.
CBCT Image Quality - Contrast to Noise Ratio
Time frame: 1 week
Contrast to Noise Ratio (CNR) measures the ability to distinguish an object or lesion from its background. CNR = |HU1 - HU2|/[0.5 (STD1 + STD2)] where HU1 and HU2 are the mean Hounsfield Unit values in two different 100 mm^2 ROIs, where the ROIs were located in two different tissue types that were relevant to the site being treated (e.g., in the liver and in perihepatic fat for liver treatments), and STD1 and STD2 are the standard deviations of the HU values in those same ROIs. A higher CNR makes it easier to distinguish an object from its background. CNR analysis was limited to images with similar imaging dose. Median CNR across all study participants treated for lung cancer are presented for three CBCT modalities.
CBCT Image Quality - HU Similarity to CT Simulation
Time frame: 1 week
The intensity of a pixel in a CT image is a function of its Hounsfield Unit (HU) value. HU is also directly related to the underlying electron density, which means that the pixel value of a CT image can be used directly in the calculation of dose for a prescribed radiation treatment plan. CT simulation scanners produce images with high HU accuracy and are regularly used for radiation treatment planning. Here, we present the difference in HU between CT simulation images and different CBCT images. ΔHU = HU_CBCT - HU_CTSim, where HU_CBCT and HU_CTSim are mean values among HU averages at 4 reference points in a CBCT image and the corresponding CT simulation image, respectively. The lower the ΔHU, the greater the HU accuracy of the CBCT image, and the greater the likelihood that CBCT imaging can be used for radiation treatment planning. Median ΔHU across the study population are presented for three different tissue types for three CBCT imaging modalities.
12 secondary outcomes
Dosimetry Calculations - Gamma Pass Rate
Time frame: 1 day
Dosimetry Calculations - Target DVH Volume Metrics
Time frame: 1 day
Dosimetry Calculations - Target DVH Dose Metrics
Time frame: 1 day
Dosimetry Calculations - Breast OAR DVH Metrics
Time frame: 1 day
Dosimetry Calculations - Lung OAR DVH Metrics
Time frame: 1 day
Dosimetry Calculations - Abdomen OAR DVH Metrics
Time frame: 1 day
Patient Experience - General Ease of Breath Hold
Time frame: 1 Day
Patient Experience - Ease of Breath Hold on TrueBeam
Time frame: 1 Day
Patient Experience - Ease of Breath Hold on Ethos
Time frame: 1 Day
Patient Experience - Relative Ease of Breath Hold Between Machines
Time frame: 1 Day
Patient Experience - Overall TrueBeam Experience
Time frame: 1 Day
Patient Experience - Overall Ethos Experience
Time frame: 1 Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBCT Imaging in people with Lung Cancer and Liver Cancer, run by Varian, a Siemens Healthineers Company at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBCT Image Quality - Artifact Index (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.