Head and Neck CancerCONFIGURENCT05524454
Evaluation of a Cone-beam CT Scanner for Image Guided Radiotherapy
A study testing Novel CBCT Imaging in people with Head and Neck Cancer and Lung Cancer, run by Varian, a Siemens Healthineers Company at 1 site in Netherlands.
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 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer, Breast Cancer
- What is being tested?
- Novel CBCT Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Mar 2023to 18 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient will be treated with external beam photon radiotherapy at Maastro for head-and-neck cancer, stage I lung cancer, stage II-IV lung cancer, left breast cancer, or tumours in the abdominal or pelvic region.
- Age ≥ 18 years
- Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician
- Provision of written informed consent
Who cannot join
- Patient is pregnant
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht Radiation Oncology
Maastricht, Limburg, 6229 ET 12
About this study
Official title: Evaluation of a Cone-beam CT Scanner for Image Guided Radiotherapy (CONFIGURE)
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 will examine the image quality generated by a new cone-beam CT (CBCT) imaging system integrated into an external beam radiation treatment delivery platform. Normally, CBCT images are acquired at the start of a daily radiation delivery treatment to align the patient with the images that were used to generate their radiation treatment plan. This alignment increases the precision of radiation delivery. This study will assess whether the improvements in image quality expected from the novel CBCT imaging system are sufficient for the images to be used for more than just patient alignment.
The study will enroll patients who will be treated with external beam radiation therapy for the following conditions: head and neck cancers, stage I lung cancer, stage II to IV lung cancer, cancer in the left breast, tumors in the abdomen, and tumors in the pelvic region. Each patient will undergo one additional imaging session with the novel CBCT imaging system during which 1 or 2 CBCT images will be acquired. The number of novel CBCT images acquired depends on the location and type of the patient's tumor. The additional imaging session will occur on the same day as one of the patient's scheduled treatment delivery sessions to minimize impact on the patient's schedule.
The patient's cancer treatment will not be affected by participation in this study. 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.
The images acquired by the novel CBCT imaging system will be compared to standard CBCT images acquired as part of the patient's treatment and to the CT simulation images used to define the patient's radiation treatment plan.
- Being tested
- Novel CBCT Imaging
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Breast Neoplasms, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel CBCT ImagingDevice
One or two CBCT images are acquired on the novel CBCT imaging system.
| Study group | Role | What they receive |
|---|---|---|
| Novel CBCT Imaging | Experimental | All subjects undergo one additional imaging session with the novel CBCT imaging system. Receives: Device: Novel CBCT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality
For this objective, the image noise level was evaluated in regions of interest representing different tissue types (muscle and fat) in both CT simulation images and HyperSight CBCT images. Image noise is the variation in image intensity, which is measured in Hounsfield Units (HU), in a region that should have uniform intensity without the presence of noise. Image noise is measured as the standard deviation of HU within the defined regions of interest. Higher noise values indicate poorer image quality. HyperSight images can be reconstructed from raw data using different reconstruction algorithms. For this analysis, both the standard Feldkamp-Davis-Kress (FDK) algorithm and an iterative metal artifact reduction (MAR) algorithm were evaluated.
Measured: Within 1 month from the start of treatment
Secondary outcomes (2)
Accuracy of Radiation Dose Calculation on HyperSight CBCT
The accuracy of dose calculation on HyperSight CBCT was evaluated by re-calculating a participant's clinical treatment plan on one of their HyperSight images and comparing the doses delivered to target structures and organs at risk (OARs). The lower the difference in dose metrics between a HyperSight CBCT-based plan and a CT simulation-based plan, the more accurate the dose calculation on HyperSight CBCT.
Both the maximum dose delivered to OARs and the mean dose delivered to OARs were compared between HyperSight-based plans and CT simulation-based plans. We report the worst overall accuracy, i.e. maximum difference in dose metrics across all OARs from across all patients. Similarly, the maximum dose delivered to the target, the mean dose delivered to the target and the minimum dose delivered to 95% of the target were compared between HyperSight CBCT-based plans and CT simulation-based plans. We report here the maximum difference across all dose metrics from across all patients.
Measured: Within 1 month from the start of treatment
Qualitative Assessment of Novel CBCT Images for Contouring Organs at Risk
CT simulation images and HyperSight CBCTs from subjects were randomly presented to expert reviewers, who were blinded to the type of image they were looking at and who were asked to rate their confidence level for contouring organs at risk (OARs) on the images using a 5-point Likert scale (very high, high, moderate, low, very low). The percentage of times that a reviewer rated their confidence level for contouring OARs on HyperSight CBCT as moderate, high, or very high was recorded. A higher percentage means a more favorable assessment for OAR contouring on HyperSight CBCT. The percentage of times the reviewer's confidence level for contouring on a HyperSight CBCT was equal to or higher than their confidence level on the corresponding CT simulation image was also recorded, where again a higher percentage means a better assessment for OAR contouring on HyperSight CBCT. The HyperSight iterative metal artifact reconstruction (MAR) algorithm was used in this analysis.
Measured: Within 1 month from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start20 Mar 2023
- Primary completion18 Aug 2023
- Study completion18 Aug 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 Head and Neck 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 a novel on-couch CBCT imaging system for anatomy visualization and radiation treatment dosimetry planning.
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT05524454
- Sponsor's protocol ID
- VAR-2022-04
- Acronym
- CONFIGURE
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2022
- Last updated
- 6 Jan 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Cone-beam CT Scanner for Image Guided Radiotherapy (CONFIGURE)
- ClinicalTrials.gov ID
- NCT05524454
- Acronym / sponsor ID
- CONFIGURE / VAR-2022-04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Posted 6 Jan 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 will examine the image quality generated by a new cone-beam CT (CBCT) imaging system integrated into an external beam radiation treatment delivery platform. Normally, CBCT images are acquired at the start of a daily radiation delivery treatment to align the patient with the images that were used to generate their radiation treatment plan. This alignment increases the precision of radiation delivery. This study will assess whether the improvements in image quality expected from the novel CBCT imaging system are sufficient for the images to be used for more than just patient alignment.
The study will enroll patients who will be treated with external beam radiation therapy for the following conditions: head and neck cancers, stage I lung cancer, stage II to IV lung cancer, cancer in the left breast, tumors in the abdomen, and tumors in the pelvic region. Each patient will undergo one additional imaging session with the novel CBCT imaging system during which 1 or 2 CBCT images will be acquired. The number of novel CBCT images acquired depends on the location and type of the patient's tumor. The additional imaging session will occur on the same day as one of the patient's scheduled treatment delivery sessions to minimize impact on the patient's schedule.
The patient's cancer treatment will not be affected by participation in this study. 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.
The images acquired by the novel CBCT imaging system will be compared to standard CBCT images acquired as part of the patient's treatment and to the CT simulation images used to define the patient's radiation treatment plan.
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 a novel on-couch CBCT imaging system for anatomy visualization and radiation treatment dosimetry planning.
| Arm | Type | Receives |
|---|---|---|
| Novel CBCT Imaging | Experimental | Device: Novel CBCT ImagingAll subjects undergo one additional imaging session with the novel CBCT imaging system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient will be treated with external beam photon radiotherapy at Maastro for head-and-neck cancer, stage I lung cancer, stage II-IV lung cancer, left breast cancer, or tumours in the abdominal or pelvic region.
- Age ≥ 18 years
- Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician
- Provision of written informed consent
Key exclusion criteria (1 listed)
- Patient is pregnant
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 |
|---|---|---|
| Novel CBCT ImagingOne or two CBCT images are acquired on the novel CBCT imaging system. | Device | Novel CBCT Imaging |
Primary outcome
Image Quality
Time frame: Within 1 month from the start of treatment
For this objective, the image noise level was evaluated in regions of interest representing different tissue types (muscle and fat) in both CT simulation images and HyperSight CBCT images. Image noise is the variation in image intensity, which is measured in Hounsfield Units (HU), in a region that should have uniform intensity without the presence of noise. Image noise is measured as the standard deviation of HU within the defined regions of interest. Higher noise values indicate poorer image quality. HyperSight images can be reconstructed from raw data using different reconstruction algorithms. For this analysis, both the standard Feldkamp-Davis-Kress (FDK) algorithm and an iterative metal artifact reduction (MAR) algorithm were evaluated.
2 secondary outcomes
Accuracy of Radiation Dose Calculation on HyperSight CBCT
Time frame: Within 1 month from the start of treatment
Qualitative Assessment of Novel CBCT Images for Contouring Organs at Risk
Time frame: Within 1 month from the start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 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 Novel CBCT Imaging in people with Head and Neck Cancer and Lung Cancer, run by Varian, a Siemens Healthineers Company at 1 site in Netherlands.
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 4 inclusion and 1 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 6 Jan 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 Netherlands. 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 Jan 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?
Image Quality (time frame: Within 1 month from the start of treatment). 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 6 Jan 2026.