Head and Neck CancerNCT06187103
Evaluation of Improved Onboard Patient Imaging
An observational study of Head and Neck Cancer and Breast Cancer, run by Varian, a Siemens Healthineers Company at 1 site in United States.
Trial summary
The primary objective of radiation therapy is to deliver a therapeutic dose of radiation precisely to the target while minimizing exposure to healthy surrounding tissues. Image-guided radiation therapy (IGRT) involves acquiring cone beam computed tomography (CBCT) scans just before or during treatment sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Breast Cancer, Upper Gastrointestinal Cancer
- What is being tested?
- HyperSight Imaging
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients receiving radiation therapy in one of five anatomical regions: head/neck, breast, lungs, upper GI and pelvis.
Who may be able to join
- Patient is willing and able to provide written consent.
- Patient is at least 18 years of age at the time of consent.
- Patient has biopsy confirmed malignancy and recommendation for definitive or palliative radiation to the head and neck, breast, lungs, upper GI structures, or pelvis.
- Patient has ECOG performance status 0-2.
- Patient will be receiving radiation therapy at University of Maryland Medical Center, Department of Radiation Oncology.
Who cannot join
- Patient is pregnant or attempting pregnancy.
- Patient has known genetic pre-disposition for sensitivity to radiation (e.g., Li Fraumeni).
- Patient receives palliative radiation for 5 or fewer fractions.
- Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response"). This includes prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201-1544
About this study
Official title: Evaluation of Improved Onboard Patient Imaging With the HyperSight Platform on TrueBeam 4.1
The primary objective of radiation therapy is to deliver a therapeutic dose of radiation precisely to the target while minimizing exposure to healthy surrounding tissues. Image-guided radiation therapy (IGRT) involves acquiring cone beam computed tomography (CBCT) scans just before or during treatment sessions. By comparing the CBCT images with the reference images from the treatment planning process, clinicians can make necessary adjustments to ensure precise targeting and account for any changes that may have occurred since the initial planning. Conventional CBCT technology is, however, limited by several factors including long acquisition times that result in motion artifacts in the image, smaller fields of view that limit the volume of anatomy that can be imaged, poor image quality that limits soft tissue visibility, and artifacts created by dense metal implants. This study will evaluate a novel CBCT imaging solution ("HyperSight") that has the potential to address the challenges of conventional CBCT.
- Conditions
- Head and Neck Cancer, Breast Cancer, Upper Gastrointestinal Cancer, Lung Cancer, Pelvic Cancer
- Being tested
- HyperSight Imaging
- Keywords
- CBCT
- Medical subject headings
- Head and Neck Neoplasms, Breast Neoplasms, Gastrointestinal Neoplasms, Lung Neoplasms, Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperSight ImagingDevice
Patients receive standard of care radiation treatment on a Varian TrueBeam system equipped with HyperSight CBCT imaging. Images acquired for daily patient positioning from two different treatment fractions - typically one near the beginning of the treatment course and one at about the halfway point - will be analyzed for the study.
| Study group | Role | What they receive |
|---|---|---|
| HyperSight Imaging arm | Subjects are imaged with the new HyperSight CBCT imaging system. Receives: Device: HyperSight Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning.
To evaluate the feasibility of HyperSight CBCT as a method for CBCT-based re-planning by measuring the fraction of patients whose HyperSight imaging meets criteria for potential CBCT-based treatment planning using HyperSight CBCT. The criteria include visibility of all key anatomical structures, image quality sufficient to contour anatomical structures, and clinically acceptable dose accuracy.
Measured: 1 year
Secondary outcomes (12)
Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning by anatomical site
To break down the fraction of patients that meet criteria for potential CBCT-based treatment planning using HyperSight CBCT by anatomical site (head/neck, breast, lungs, upper GI tract, and pelvis).
Measured: 1 year
Image noise
To evaluate the imaging noise in HyperSight CBCT using clinical images and to compare this aspect of image quality to simulation CT images.
Measured: 1 year
Image low-contrast resolution
To evaluate contrast between adjacent anatomical structures in HyperSight CBCT using clinical images and to compare this aspect of image quality to simulation CT images.
Measured: 1 year
Image contrast-to-noise ratio
To measure the contrast-to-noise ratio of HyperSight CBCT using clinical images and to compare this aspect of image quality to simulation CT images.
Measured: 1 year
Qualitative assessment of motion artifacts
To evaluate the severity of motion artifacts observed in HyperSight CBCT using clinical images and to compare motion artifacts to simulation CT. Qualitative assessments will be performed by independent observers using a 5-point Likert scale.
Measured: 1 year
Qualitative assessment of metal artifacts
To evaluate the severity of metal artifacts observed in HyperSight CBCT in head \& neck patients with dental fillings and pelvis patients with hip prostheses and compare metal artifacts between HyperSight CBCT and simulation CT. Qualitative assessments will be performed by independent observers using a 5-point Likert scale, with a score of 1 representing very severe metal artifacts and a score of 5 representing little or no artifact..
Measured: 1 year
Comparison of anatomical structure contours defined on HyperSight and conventional imaging.
To evaluate concordance of anatomical structures contoured on HyperSight with anatomical structures contoured on simulation CT as measured by the Dice Similarity Coefficient.
Measured: 1 year
Comparison of anatomical structure contours defined on HyperSight and conventional imaging.
To evaluate concordance of anatomical structures contoured on HyperSight with anatomical structures contoured on simulation CT as measured by Hausdorff Distance.
Measured: 1 year
Breath hold tolerance
To evaluate the number of breath holds required for patients with breast, thoracic, and upper GI malignancies during HyperSight CBCT imaging.
Measured: 1-9 weeks
Patient experience of HyperSight imaging
To evaluate patient experience of HyperSight imaging. Patients will be asked to fill out a questionnaire. Questions will use a 5-point Likert scale.
Measured: 1-9 weeks
Impact of noise suppression
HyperSight CBCT images will be reconstructed with different levels of noise suppression and compared qualitatively to CT simulation images of the same patient to identify regions adversely affected by too much or too little noise suppression. This evaluation will be performed for 1-2 subjects in each anatomical region.
Measured: 1 year
Effectiveness of AI auto-contouring
The ability of AI auto-contouring to accurately contour structures on Hy[erSight CBCT will be evaluated (i) via qualitative user feedback on the accuracy of the auto-generated contours, and (ii) quantitatively using overlap metrics (Hausdorff Distance and Dice Similarity Coefficient) to compare auto-generated critical organs at risk to anatomical structures manually contoured on HyperSight CBCT.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start10 Jul 2024
- Primary completion5 Dec 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 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
- NCT06187103
- Sponsor's protocol ID
- VAR-2023-05
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Improved Onboard Patient Imaging With the HyperSight Platform on TrueBeam 4.1
- ClinicalTrials.gov ID
- NCT06187103
- Acronym / sponsor ID
- VAR-2023-05
- Conditions
- Head and Neck Cancer, Breast Cancer, Upper Gastrointestinal Cancer, Lung Cancer, Pelvic Cancer
- Keywords
- CBCT
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of radiation therapy is to deliver a therapeutic dose of radiation precisely to the target while minimizing exposure to healthy surrounding tissues. Image-guided radiation therapy (IGRT) involves acquiring cone beam computed tomography (CBCT) scans just before or during treatment sessions. By comparing the CBCT images with the reference images from the treatment planning process, clinicians can make necessary adjustments to ensure precise targeting and account for any changes that may have occurred since the initial planning. Conventional CBCT technology is, however, limited by several factors including long acquisition times that result in motion artifacts in the image, smaller fields of view that limit the volume of anatomy that can be imaged, poor image quality that limits soft tissue visibility, and artifacts created by dense metal implants. This study will evaluate a novel CBCT imaging solution ("HyperSight") that has the potential to address the challenges of conventional CBCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HyperSight Imaging arm | – | Device: HyperSight ImagingSubjects are imaged with the new HyperSight CBCT imaging system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving radiation therapy in one of five anatomical regions: head/neck, breast, lungs, upper GI and pelvis.
Key inclusion criteria (5 listed)
- Patient is willing and able to provide written consent.
- Patient is at least 18 years of age at the time of consent.
- Patient has biopsy confirmed malignancy and recommendation for definitive or palliative radiation to the head and neck, breast, lungs, upper GI structures, or pelvis.
- Patient has ECOG performance status 0-2.
- Patient will be receiving radiation therapy at University of Maryland Medical Center, Department of Radiation Oncology.
Key exclusion criteria (4 listed)
- Patient is pregnant or attempting pregnancy.
- Patient has known genetic pre-disposition for sensitivity to radiation (e.g., Li Fraumeni).
- Patient receives palliative radiation for 5 or fewer fractions.
- Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response"). This includes prisoners.
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 |
|---|---|---|
| HyperSight ImagingPatients receive standard of care radiation treatment on a Varian TrueBeam system equipped with HyperSight CBCT imaging. Images acquired for daily patient positioning from two different treatment fractions - typically one near the beginning of the treatment course and one at about the halfway point - will be analyzed for the study. | Device | HyperSight Imaging arm |
Primary outcome
Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning.
Time frame: 1 year
To evaluate the feasibility of HyperSight CBCT as a method for CBCT-based re-planning by measuring the fraction of patients whose HyperSight imaging meets criteria for potential CBCT-based treatment planning using HyperSight CBCT. The criteria include visibility of all key anatomical structures, image quality sufficient to contour anatomical structures, and clinically acceptable dose accuracy.
12 secondary outcomes
Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning by anatomical site
Time frame: 1 year
Image noise
Time frame: 1 year
Image low-contrast resolution
Time frame: 1 year
Image contrast-to-noise ratio
Time frame: 1 year
Qualitative assessment of motion artifacts
Time frame: 1 year
Qualitative assessment of metal artifacts
Time frame: 1 year
Comparison of anatomical structure contours defined on HyperSight and conventional imaging.
Time frame: 1 year
Comparison of anatomical structure contours defined on HyperSight and conventional imaging.
Time frame: 1 year
Breath hold tolerance
Time frame: 1-9 weeks
Patient experience of HyperSight imaging
Time frame: 1-9 weeks
Impact of noise suppression
Time frame: 1 year
Effectiveness of AI auto-contouring
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- 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?
An observational study of Head and Neck Cancer and Breast Cancer, run by Varian, a Siemens Healthineers Company at 1 site in United States.
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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 21 Apr 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Fraction of patients whose HyperSight CBCT images meet the criteria for CBCT-based treatment planning. (time frame: 1 year). 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 21 Apr 2026.